BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBULIFT

    MDR report key: 2110976 · Received April 29, 2011

    Report

    Report Number
    9611530-2011-00031
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED AB LTD (UNDER REGISTRATION (B)(4)). AS OF (B)(4) 2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJO HOSPITAL EQUIPMENT AB AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION (B)(4). FURTHER INFO WILL BE PROVIDED UPON MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE NOMINATED INVESTIGATOR THAT THE CARER WAS BATHING THE PT. THE CARER LOWERED THE CHAIR AND ASSISTED THE PT ONTO THE CHAIR THEN RAISED HIM UP AND TURNED HIM INTO THE BATH THEN LOWERED HIM TO BATHE. ONCE FINISHED, THE CARER THEN RAISED THE CLIENT OUT OF THE WATER AND TURNED HIM OUT OF THE BATH. WHILST THE PT WAS IN MID AIR, THE CHAIR BECAME DETACHED FROM THE JIB CAUSING THE PT TO FALL TO THE FLOOR. THE PT WAS COMFORTED ON THE FLOOR BY THE CARER WHO THEN RAISED THE ALARM BECAUSE THE PT WAS COMPLAINING OF LOWER BACK PAIN. THE UNIT MANAGER THEN CALLED AN AMBULANCE WHICH CAME AND TOOK THE PT TO HOSPITAL FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBULIFT PASSIVE FLOOR LIFTS FSA ARJO MED AB LTD AA0550-06

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization