BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1700 SEMI AUTOMATIC DEFIBRILLATOR

    MDR report key: 1722652 · Received December 7, 2009

    Report

    Report Number
    1220908-2009-03568
    Event Type
    Malfunction
    Date Received
    December 7, 2009
    Report Date
    November 18, 2009
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    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 EVALUATION 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 WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA THE MULTIFUNCTION SIGNAL CABLE. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1700 SEMI AUTOMATIC DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 1700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA