BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMERSION HYDROBATH

    MDR report key: 2884530 · Received December 22, 2012

    Report

    Report Number
    1525712-2012-03243
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Report Date
    December 21, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL IH3650, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY TWO YEARS OLD. ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THIS EVENT, ALTHOUGH FOUR DIFFERENT COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT PARTS NEEDED TO REPAIR THE UNIT, AND THE NUMBERS ARE THE FOLLOWING: (B)(4). THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE AND THE MAINTENANCE HISTORY OF THE DEVICE ARE UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE IH3650 TUB DOOR SEAL AND THE JETS WERE LEAKING. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMERSION HYDROBATH 890.5100 ILJ INVACARE TAYLOR STREET IH3650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other