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Can anyone shed some light on what types of medical device complaints need to be reported? Years ago we used to only report adverse incidents that was caused or contributed by our medical device. Now that I am working for a different company, this company's policy is to report any incident that could possibly cause or contribute to an adverse event. They said that the FDA has become much more strict yet cannot show me a regulation that states this. Here are a couple of examples of incidents that I would not think are reportable and they do.
1. A sterilizer has a leak and water gets on the floor. The amount of water on the floor extends past the footprint of the machine. Even though no one slipped and fell, this would be reported.
2. A display monitor looses the image due to a power failure, unplugged cord, or another reason. Even though a secondary monitor continues to display the image, this would be considered reportable.
I would appreciate any advice on this topic.
1. A sterilizer has a leak and water gets on the floor. The amount of water on the floor extends past the footprint of the machine. Even though no one slipped and fell, this would be reported.
2. A display monitor looses the image due to a power failure, unplugged cord, or another reason. Even though a secondary monitor continues to display the image, this would be considered reportable.
I would appreciate any advice on this topic.
