BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBULIFT BSQ

    MDR report key: 1785786 · Received July 22, 2010

    Report

    Report Number
    9611530-2010-00047
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MFG BY ARJO HOSP EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MFR, ARJO HOSP EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION. TRACK WISE ID.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER 2010-(B)(6): IT WAS REPORTED BY THE CUSTOMER THAT THE RESIDENT WAS BEING TRANSPORTED BACK TO HER ROOM ON WHEELED BATH CHAIR, (TAKEN INTO BATHROOM ON SAME EQUIPMENT), ON RETURN TO HER ROOM THE CARER WHILST PUSHING CHAIR HEARD A CRACKING NOISE, SHE LOOKED AND SAW CHAIR SLIPPING FROM ITS BASE, TRIED TO PUSH IT BACK ON, CALLED FOR EMERGENCY ASSISTANCE AND EASED RESIDENT TO FLOOR. SHE WAS WORRIED ABOUT RESIDENT LEGS BENDING UNDERNEATH AND THEN TRIED TO PREVENT HER GETTING HURT, THAT'S WHY I DID WHAT I DID. AFTER THE INCIDENT A PIECE OF METAL AND PLASTIC STRIP WERE FOUND ON THE FLOOR, LADY (RESIDENT) WAS SENT TO HOSP. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBULIFT BSQ LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB AA0550

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR