BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER BATH

    MDR report key: 2960807 · Received February 11, 2013

    Report

    Report Number
    9611530-2013-00014
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 21, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT IS BEING SUBMITTED UNDER EXEMPTION (B)(4) BY THE MANUFACTURER ARJO HOSPITAL (B)(4) ON BEHALF OF THE IMPORTER (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE PARKER BATH IS A HEIGHT ADJUSTABLE BATH FOR ASSISTED BATHING. IT WAS REPORTED TO US THAT THE BATH WAS FILLED AND IN HIGHEST POSITION. THE "CARER" WANTED TO LOWER THE BATH BUT IT DIDN'T MOVE. ASSUMING MAYBE THE WEIGHT FROM THE WATER WAS CAUSING THE BLOCKAGE, THE CUSTOMER EMPTIED THE BATH. THIS DIDN'T HELP. HE COULD HEAR THE ACTUATOR WHEN TRYING TO ACTION HI-LO MOVEMENT BUT NOTHING ELSE HAPPENED. WHEN TRYING TO TILT THE BATH MANUALLY, THE TUB KIND OF FELL DOWN 20-30CM. AFTER THIS EVENT THE BATH FUNCTIONS NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60011 PARKER BATH BATH SYSTEMS ILJ ARJO HOSPITAL EQUIPMENT AB AL11110-EU

    Patients

    Seq Age Sex Outcome Treatment
    1