BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1082785 · Received July 23, 2008

    Report

    Report Number
    1220908-2008-01686
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A FEMALE PT, THE DEVICE CHARGED ENERGY ON TWO ATTEMPTS, HOWEVER, WOULD NOT DISCHARGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION. CLINICIANS NOTED THAT THE PT HAD AN OILY RESIDUE AND THE ELECTRODES USED IN THE EVENT WERE DISPOSED OF AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORP. MSERIES BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR