BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL FETAL MONITOR

    MDR report key: 38133 · Received September 16, 1996

    Report

    Report Number
    MW1009927
    Event Type
    Malfunction
    Date Received
    September 16, 1996
    Date of Event
    September 11, 1996
    Report Date
    September 12, 1996
    Manufacturer
    GRAPHIC CONTROLS
    Product Code
    HFM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RPTR OPENED A BRAND NEW PACKAGE WHICH HAD PIECE OF WHAT LOOKED LIKE BLACK ELECTRICAL TAPE ON THE BELT. RPTR REMOVED THE TAPE TO SEE WHAT WAS UNDER IT AND FOUND THAT THE BELT HAD BEEN CUT AND TAPED BACK TOGETHER WITH BLACK ELECTRICAL TAPE. THIS MUST HAVE BEEN DONE AT THE FACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL FETAL MONITOR MONITOR BELT FOR EXTERNAL FETAL MONITOR HFM GRAPHIC CONTROLS * 9616340

    Patients

    Seq Age Sex Outcome Treatment
    1 *