BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1030495 · Received April 16, 2008

    Report

    Report Number
    1220908-2008-00747
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Report Date
    March 26, 2008
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    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 DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "PACER FAULT 117" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    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 NA