Medical Device Malfunction

Medical Device Reporting (MDR): How to Report Medical …

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

Medical Device Reporting (MDR): How to Report Medical Device Problems Manufacturers, Importers, and Device User Facilities: This page is designed to provide you with information on mandatory...

Medical Device Reporting (MDR): How to Report Medical …

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

Overview of Medical Device Reporting. Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious …

Seven serious medical device malfunctions that have led to …

https://www.nsmedicaldevices.com/analysis/medical-device-failures-fda-recalls/

MDR Adverse Event Codes | FDA

https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes

Attachment C: Summary of MDR Reporting …

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/attachment-c-summary-mdr-reporting-requirements

The malfunction involves a long-term implant or a device that is considered to be life-supporting or life-sustaining and thus is essential to maintaining human life. …

Medical Device Makers Report …

https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/

But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA, many implanted in patients or used in countless surgeries....

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=803.3

(k) Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include …

Reporter finds millions of hidden reports of medical …

https://journalistsresource.org/politics-and-government/fda-medical-device-injury-reports-investigation/

Jewett’s reporting uncovered half a million reports of injuries or malfunctions tied to breast implants; some 66,000 surgical stapler malfunctions and more than …

Examples of Medical Device Misconnections | FDA

https://www.fda.gov/medical-devices/medical-device-connectors/examples-medical-device-misconnections

In order to physically prevent device misconnections from occurring, standardized connector designs for specific medical applications are being developed. …

What You Can Do When Medical Devices Malfunction - Online …

https://onlinehealthmedia.com/medical-devices-malfunction/

A medical device malfunction occurs when a piece of equipment fails to perform its intended use. Patients, caregivers, healthcare professionals, and hospitals …