BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 2891262 · Received November 27, 2012

    Report

    Report Number
    1220908-2012-03234
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
    Product Code
    MKJ
    PMA / PMN Number
    K990762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE¿S DEFIB OUTPUT WAS OUT OF SPECIFICATION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS MSERIES BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA