Medical Device Safety

A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They range from small and simple, like a blood glucose meter, to large and complicated, like a ventilator. You might use one at home or at work, or you may need one in a hospital.

To use medical devices safely

• Know how your device works. Keep instructions close by
• Understand and properly respond to device alarms
• Have a back-up plan and supplies in the event of an emergency
• Keep emergency numbers available and update them as needed
• Educate your family and caregivers about your device (Food and Drug Administration)

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Medical Device Retraction Problem

Issue associated with drawing back the device and/or device component to an intended location.

Medical Device Reset Issue

Issue associated with setting a variable, register, or other storage location back to a prescribed state.

Medical Device Protective Measure Issue

Issue associated with any deviations from device documented performance specifications relating to the implemented and inherited design features specific to devices used…

Medical Device Problem Codes FDA CDRH

Terminology used for defining mode of medical device failure or malfunction in individual case reports for voluntary and mandatory reporting of adverse…

Medical Device Pressure Issue

Issue associated with the application of a force either internal or external to the device that compromises the flow of fluid or…

Medical Device Position Issue

Issue associated with the movement of the device and/or device components to an intended location.