BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALIBU

    MDR report key: 1397279 · Received March 26, 2009

    Report

    Report Number
    9611530-2009-00021
    Event Type
    Malfunction
    Date Received
    March 26, 2009
    Date of Event
    March 20, 2009
    Report Date
    March 26, 2009
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT AS THEY WERE ROTATING THE SEAT AROUND INTO THE BATH DURING A PT TRANSFER, THERE WAS A LOUD BANG. SUDDENLY, THE ARM AND SEAT ASSEMBLY TIPPED OVER, DROPPING THE RESIDENT INTO THE BATH AND POPPING THE SIDE OF THE BATH OUT. NO INJURIES WERE REPORTED. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALIBU BATHING SYSTEM ILJ ARJO HOSPITAL EQUIPMENT AB AJLXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention