Reporting Defective Medical Equipment

Medical Device Reporting (MDR): How to …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

FDA Guidance: Medical Device Reporting for User Facilities (PDF Only) (PDF - 313KB) For Questions about Medical Device Reporting, including interpretation of MDR policy: Call: (301) 796-6670...

Recalls, Corrections and Removals (Devices) | FDA

https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices

Report a Problem to the FDA | FDA - U.S. Food and …

https://www.fda.gov/safety/report-problem-fda

It also oversees medicines, medical devices (from bandages to artificial hearts), blood products, vaccines, cosmetics, animal food (including pet food) and animal …

Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

If you wish to find information on a recall, or a correction or removal action that has not yet been classified, you can search the Medical Device Recalls Database. …

Medical device reporting—a model for …

https://www.myamericannurse.com/medical-device-reporting-model-patient-safety/

If the device is disposable, save the packaging for device identifiers (manufacturer name, brand name, model, catalog number, lot number). Another …

Defective Medical Devices - FindLaw

https://www.findlaw.com/injury/product-liability/defective-medical-devices.html

Dangerous or defective medical devices -- such as faulty surgical instruments, implants, pacemakers, and prosthetics -- can give rise to a product liability …

Medical Equipment Management Plan - Duke …

https://www.safety.duke.edu/sites/default/files/Medical-Equipment-Management-Plan.pdf

Clinical Engineering documents all work performed on routine (non -high-risk) equipment included in the medical equipment inventory plan in accordance with all applicable …

How to Report Dangerous Products and What to Report

https://www.consumersafety.org/resources/report-unsafe-products/

Complaints are collected by the Occupational Safety & Health Administration (OSHA), and all information is kept confidential from employers. If you …

Handling of Malfunctioning or Defective Equipment …

https://www.utmb.edu/policies_and_procedures/7996156

If equipment, devices, or supplies appear to be defective, or are believed to have malfunctioned, the item shall be removed for service and tagged. Complete and attach a …