BEUDAMED
    FDA Adverse Event Summary report: N

    AMBULIFT

    MDR report key: 2222827 · Received August 1, 2011

    Report

    Report Number
    9611530-2011-00061
    Date Received
    August 1, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 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

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (REGISTRATION#(B)(4)) ON BEHALF OF THE MANUFACTURER ARJO HOSPITAL EQUIPMENT (B)(4) (REGISTRATION#(B)(4)). PLEASE NOTE THAT WHILE THIS PRODUCT IS NO LONGER MANUFACTURED, PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO (B)(4) (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 (B)(4) AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION # (B)(4). THE HOIST HAS BEEN REMOVED FROM SERVICE UNTIL FURTHER NOTICE DUE TO NON-AVAILABILITY OF REPLACEMENT PARTS. THE DEVICE WAS INVOLVED IN A PREVIOUSLY REPORTED INCIDENT, UNDER MFR# 9611530-2011-00031. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER 2011-(B)(6) "THE RESIDENT HAD BEEN PUT IN THE BATH AND ON REMOVAL AFTER LIFTING RESIDENT'S LEG TO CLEAR BATH, CARERS STARTED TO DRESS RESIDENT, THE CHAIR FELL FROM HANDLE HEIGHT OFF THE HOIST (AMBULIFT), HIT THE LIP OF THE BATH CAUSING A CHIP AND LANDED UPRIGHT, WITH NO APPARENT INJURY TO THE RESIDENT TO DATE, (RESIDENT DOES NOT COMMUNICATE NORMALLY)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBULIFT PASSIVE FLOOR LIFTS FSA ARJO MED AB LTD AA055-06

    Patients

    Seq Age Sex Outcome Treatment
    1 Other