BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALIBU

    MDR report key: 2110957 · Received March 15, 2011

    Report

    Report Number
    9611530-2011-00026
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NUMBER (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2011: IT WAS REPORTED BY THE CUSTOMER THAT WHEN LOWERING A LADY PT INTO THE BATH THE SEAT SHELL CAME AWAY FROM THE SEAT FRAME AND THE SEAT AND LADY SLIPPED DOWN INTO THE BATH. THE LADY BUMPED HER HEAD BUT WITH NO SERIOUS INJURY. THE TEXT THAT FOLLOWS WAS TAKEN FROM THE IDF: THE LADY WAS TAKEN TO THE BATHROOM AND HOISTED FROM HER CHAIR TO THE BATH SEAT, THE BATH SEAT WAS OPERATED USING THE HAND SET AND LIFTED THE LADY AND SWUNG HER AROUND INTO THE TUB ABOVE THE WATER, THE SEAT THEN STARTED TO LOWER AND AS THE CHAIR REACHED THE WATER THE COMMODE SEAT SHELL AND RESIDENT FLOATED OFF THE CHAIR FRAME. THE LADY BUMPED HER HEAD ON THE BACK REST AS SHE FLOATED. THE CARER SUPPORTED THE RESIDENT AND CALLED FOR ASSISTANCE, ONCE ASSISTANCE ARRIVED THE RESIDENT AND SEAT SHELL WAS PLACED BACK OVER THE SEAT FRAME AND RAISED SO SHE WAS OUT OF THE WATER, THE RESIDENT WAS SHOWERED AND THEN REMOVED FROM THE BATH USING THE BATH CHAIR. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALIBU BATH, SITZ, POWERED FSA ARJO HOSPITAL EQUIPMENT AB AI*

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR