BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSCD

    MDR report key: 246619 · Received October 26, 1999

    Report

    Report Number
    MW1017414
    Event Type
    Malfunction
    Date Received
    October 26, 1999
    Report Date
    October 26, 1999
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    KSD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPEATED WELD FAILURES ON NEW EQUIPMENT. DEVICE WAS PUT INTO SERVICE 4/5/99. FIRST WELD FAILURES OCCURRED ON 4/9/1999. INTERMITTENT PROBLEMS W/ TWO OTHER DEVICES (SAME MODEL), INCLUDING WAFER JAMS AND FAILED WELDS LEADING TO PRODUCT LOSS. THE FIRST DEVICE WAS RETURNED FOR SERVICING 7/99 AND WAS PLACED BACK IN SERVICE 10/5/99. FAILED WELD OCCURRED ON 10/5/99. RETURNED FOR SERVICING /REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSCD STERILE TUBING WELDER KSD TERUMO MEDICAL CORP. TSCD NA
    2 TSCD STERILE TUBING WELDER KSD TERUMO MEDICAL CORP. TSCD NA
    3 TSCD STERILE TUBING WELDER KSD TERUMO MEDICAL CORP. TSCD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other TSCD SC201A