BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 297899 · Received September 22, 2000

    Report

    Report Number
    1220908-2000-01002
    Event Type
    Malfunction
    Date Received
    September 22, 2000
    Report Date
    August 25, 2000
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    KRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING PT SET-UP (AGE AND GENDER UNKNOWN), THE DEVICE ENERGY OUTPUT WAS UNABLE TO BE ADJUSTED IN LEAD 2. ZOLL HAS BEEN UNSUCCESSFUL IN OBTAINING ANY ADD'L EVENT INFO FROM THE COMPLAINANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other