Device shows an Error message - Malfunction or not?

L

luloo117117

#1
In order to protect the user, the medical device we designed has a inside temperature monitor. When the inside temperature is too high the device will automatically show an error message "temperature is too high" on the control screen and turn the device OFF. Then the users can not continue to do the treatment by the product at that moment.

Questions:
One user used our medical device. One day the user reported the devie showed the error message "temperature is too high". Should we regard this is device malfunction?

My understanding is if the device did not show error message to customer when the temperature is too high, then it is "MALFUNCTION"!!! But if it showed the error message, it is still functional (not malfunction).

I do not know my understanding is right or not?

Leon
 
Elsmar Forum Sponsor
S

Sorin

#2
Re: Malfunction or not?

In order to protect the user, the medical device we designed has a inside temperature monitor. When the inside temperature is too high the device will automatically show an error message "temperature is too high" on the control screen and turn the device OFF. Then the users can not continue to do the treatment by the product at that moment.

Questions:
One user used our medical device. One day the user reported the devie showed the error message "temperature is too high". Should we regard this is device malfunction?
If the real temperature was high there is no malfunction.
If the real temperature was different and the one registered by device was out of tolerance, then that is a malfunction.

IMO...
 
#3
Re: Malfunction or not?

I see this from two different angles. First, if the temp is too high, and the message read, as designed, then the fail safe system is not malfunctioning. It is working as it should.
However, my question is why is the temp getting too high? Could the high temp be a symptom of a malfunction? It almost sounds like the device design is not robust enough for actual use. But, of course, it is impossible for me to say with just the information at hand.
 
L

luloo117117

#4
Re: Malfunction or not?

There are lots of reasons can cause the inside temperature is too high (for example, 41C). Too high temperature can shorten the device lifetime and give inaccurate output to patient. To mitigate this risk, we put a temperature sensor inside.

The reason why I ask if it falls under "Malfunction" is that if it is we should report to authorities.

So does that mean it is malfunction if show error message to customer and turn off device?
 
I

icare2much

#5
Is the device being used as intended? Is it being used within the environmental conditions specified in the device labeling?

If the device is being used as directed, and it is shutting down, designed that way or not, it is a valid complaint.
 
L

luloo117117

#6
I do think it is a complaint from customer.

But is it malfunctional or not if it is used same as describled in User Manual.

The device did what it was designed to show the error message to customer.
 
I

icare2much

#7
Does the user manual provide instruction that this event could occur? Does it explain the error code?

I don't believe that the display of the error code is a malfunction, as you said, that is a protective safety measure that has been designed in. What concerns me more is that the device, during normal use, as prescribed in the instruction manual, has experienced an internal rise in temperature sufficient enough to engage the overheat protection.

The malfunction is that the device experienced the temperature rise under normal use. Unless you specify in you manual under what conditions it could experience this temperature rise, in my opinion it is a fault.

From how you describe it, it doesn't appear to be a manufacturing fault, it seems like a design flaw.
 

somashekar

Staff member
Super Moderator
#8
Re: Malfunction or not?

There are lots of reasons can cause the inside temperature is too high (for example, 41C). Too high temperature can shorten the device lifetime and give inaccurate output to patient. To mitigate this risk, we put a temperature sensor inside.

The reason why I ask if it falls under "Malfunction" is that if it is we should report to authorities.

So does that mean it is malfunction if show error message to customer and turn off device?
While I cannot call it a malfunction based on what is said so far, my question to you is has the design validation not effectively done to capture such occurances before the customer reflects it back on you ...
Is it too safe not to be performing its intended application in the intended environment ?
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#9
Re: Malfunction or not?

While I cannot call it a malfunction based on what is said so far, my question to you is has the design validation not effectively done to capture such occurances before the customer reflects it back on you ...
Is it too safe not to be performing its intended application in the intended environment ?
I agree. Also, is it a problem for the patient that the treatment stops in the middle? If so, then I would look at it as a malfunction - even if it is expected. Just because it tells you - accurately - that it is "not functioning - is stopping its actual function a malfunction related to the success of the treatment?

Another analogy:

Your check engine light comes on because the engine overheated. The check engine light did its job. No malfunction?
 

Jim Wynne

Staff member
Admin
#10
Re: Malfunction or not?

Your check engine light comes on because the engine overheated. The check engine light did its job. No malfunction?
Whether there's a malfunction or not would depend on what caused the overheating, no? Failure to attend to a coolant leak might not be the manufacturer's problem.
 
Thread starter Similar threads Forum Replies Date
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
T Device & Accessory, Components in device, or System EU Medical Device Regulations 0
shimonv Clinical evaluation report for class I device EU Medical Device Regulations 3
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 0
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
M Sample record for verification performed by importers before placing a device on the market EU Medical Device Regulations 0
S IVD Device History Record ISO 13485:2016 - Medical Device Quality Management Systems 3
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
K How to handle GTINs for different configurations of one device with one part number? Other Medical Device Related Standards 0
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
C Multiple owners for one listed device Medical Device and FDA Regulations and Standards News 1
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
J Promoting and marketing of a non approved device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B Russian Device to US US Food and Drug Administration (FDA) 5
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
V MDSAP Requirements for Device Designer Canada Medical Device Regulations 1
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
E Procedure ( SOP) for Device Master Record ( DMR ) and for Device History Record (DHR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
J US Device Listing when not the 510(k) owner Medical Device and FDA Regulations and Standards News 2
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
G Voluntary Class I Device Filing Other US Medical Device Regulations 4
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
S Medical Device MRI Compatibility EU Medical Device Regulations 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5

Similar threads

Top Bottom