BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITZ BATH 1616700692

    MDR report key: 4604600 · Received March 16, 2015

    Report

    Report Number
    1219590-2015-00059
    Event Type
    Malfunction
    Date Received
    March 16, 2015
    Date of Event
    March 5, 2015
    Report Date
    March 5, 2015
    Manufacturer
    INVACARE CLEVELAND STREET
    Product Code
    KTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE LEAK IN THE PLUMBING WAS REPAIRED AND OPERATING THE JET MOTORS, IT KEPT TRIPPING THE GFI BREAKER. WHEN THE TUB WAS LEAKING WATER BEFORE, IT GOT INTO THE CONTROL BOX WIRING CAUSING IT TO SHORT OUT AND TRIP THE GFI BREAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177801 SITZ BATH 1616700692 BATH, SITZ, NONPOWERED KTC INVACARE CLEVELAND STREET IH3652G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other