BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED10

    MDR report key: 2031666 · Received February 24, 2011

    Report

    Report Number
    1220908-2011-00435
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED10 AUTOMATED EXTERNAL DEFIB MKJ ZOLL MEDICAL CORP AED10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA