BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCTOSCOPE POWER TRANSFORMER

    MDR report key: 970328 · Received December 20, 2007

    Report

    Report Number
    MW5004778
    Event Type
    Malfunction
    Date Received
    December 20, 2007
    Date of Event
    November 8, 2007
    Report Date
    December 20, 2007
    Manufacturer
    WELCH ALLYN HOLDINGS INC
    Product Code
    GCF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    TRANSFORMER UNIT IS COMING APART AT THE PLUG HOUSING, EXPOSING THE ELECTRICAL WIRES AND CIRCUIT BOARD. THIS IS THE SECOND TRANSFORMER UNIT THIS HAS HAPPENED TO. THE FIRST TIME IT HAPPENED, ABOUT 3 MONTHS AGO, WE REPORTED IT DIRECTLY TO THE COMPANY AND RECEIVED A NEW ONE IN RETURN. IT APPEARS THAT THE PLASTIC PRONGS DESIGNED TO HOLD THE HOUSING TOGETHER ARE BREAKING FAR TOO EASILY. THIS IS A PIECE OF DURABLE MEDICAL EQUIPMENT. BUT WHEN THEY STARTED BREAKING THE FIRST TIME, WE HAD ORDERED SOME EXTRA TRANSFORMERS JUST IN CASE. WE USED THE LAST ONE OF THOSE EXTRAS TO KEEP THE SET OPERATIONAL THIS WEEK, SO THE NEXT TIME ONE BREAKS, THE OR WILL BE DOWN ONE PROCTOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCTOSCOPE POWER TRANSFORMER PROCTOSCOPE POWER TRANSFORMER GCF WELCH ALLYN HOLDINGS INC 73305

    Patients

    Seq Age Sex Outcome Treatment
    1 YR