Medical Devices Failures

Seven serious medical device failures that have led to …

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

Allergan breast implants. In July 2019, US pharma …

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

Submit reports to the FDA through the MedWatch program in one of the following ways: Complete the MedWatch Online Reporting Form. Download form or call 1-800-332-1088 …

Medical Device Makers Report Malfunctions And Patient Injuries …

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

The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely …

The grim stories behind seven of medtech’s worst …

https://www.medicaldesignandoutsourcing.com/the-grim-stories-behind-seven-of-medtechs-worst-failures/

The grim stories behind seven of medtech’s worst failures. April 19, 2019 By Danielle Kirsh. [Image by managing editor Chris …

Mitigating Risks of Materials Failures in Medical Devices

https://www.mddionline.com/materials/mitigating-risks-materials-failures-medical-devices

7 Recent Medical Device Failures Catching FDA's Eye

https://www.mddionline.com/7-recent-medical-device-failures-catching-fdas-eye

Here are some of the major medical device failure events since January: 1. Inadequate Sterilization for an Orthopedic Surgery Tool. The FDA is warning that a Greatbatch Medical Orthopedic surgical tool could cause serious …

9 Ways Medical Devices Fail | mddionline.com

https://www.mddionline.com/business/9-ways-medical-devices-fail

Medical device recalls appear to be growing at a slower pace than the device industry itself. But when they do happen, they can produce tragic, even deadly, results for patients. MPMN asked members …

Epic Fails in Medical Device History | Medical-Sales …

https://www.medreps.com/medical-sales-careers/epic-fails-in-medical-device-history

AEDs automatically diagnose abnormal heart rhythms and deliver shocks to people in cardiac arrest. The problem is, they don’t always work. The industry has conducted about 90 recalls over the past several …

7 Medical Device Failures Causing Serious Recalls

https://www.mddionline.com/7-medical-device-failures-causing-serious-recalls

3. Software Defects. Software problems continue to be one of the most common reasons for medical device recalls. Examples of recent software problems that have led to Class I-recalls include a Dräger recall of a …

Common failures and delays when developing a …

https://prgnpi.com/common-failures-developing-a-medical-device/

In medical devices, the failures are usually from a lack of understanding of how long development is s going to take. Extra time is needed because of the regulations, for obtaining FDA approval, and for obtaining …