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Seven serious medical device malfunctions that …

    https://www.nsmedicaldevices.com/analysis/medical-device-failures-fda-recalls/
    Seven serious medical device failures. 1. Allergan breast implants. In July 2019, US pharma and …

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 …

Mitigating Risks of Materials Failures in Medical Devices

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

    Five Common Causes of Medical Device Failure

      https://www.mddionline.com/testing/five-common-causes-medical-device-failure

      7 Recent Medical Device Failures Catching FDA's Eye

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

        9 Ways Medical Devices Fail | mddionline.com

          https://www.mddionline.com/business/9-ways-medical-devices-fail
          MPMN:This issue can even extend to instructions, as demonstrated by two medical device failure issues that recently caught the FDA's eye. Thoratec Corp. …

        The grim stories behind seven of medtech’s …

          https://www.medicaldesignandoutsourcing.com/the-grim-stories-behind-seven-of-medtechs-worst-failures/
          The FDA, for example, is already considering a reboot of the 510(k) clearance pathway, which critics say allows unsafe and ineffective devices onto the market. …

        The Top 7 Reasons Why Medical Devices …

          https://boydbiomedical.com/articles/the-top-7-reasons-why-medical-devices-fail
          6) Insufficient maintenance. Most medical devices require maintenance on an annual or semi-annual basis. Through proper testing and analysis, manufacturers …

        Epic Fails in Medical Device History

          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 …

        7 Medical Device Failures Causing Serious …

          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 …



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