BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBULIFT

    MDR report key: 2223539 · Received July 22, 2011

    Report

    Report Number
    9611530-2011-00058
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    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

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE MFR ARJO HOSPITAL (B)(4). PLEASE NOTE THAT WHILE THIS PRODUCT IS NO LONGER MANUFACTURED, PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE ARJO (B)(4). AS OF 06/15/2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MFR. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJO HOSPITAL (B)(4) AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER (B)(4). CURRENTLY, THE NURSING HOME WILL NOT ALLOW AN ARJOHUNTLEIGH INVESTIGATOR TO EXAMINE THE LIFTER IN QUESTION UNTIL THEIR OWN H&S TEAM HAS INVESTIGATED THE INCIDENT. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE PT WAS LOWERED ONTO THE CHASSIS WHILE SEATED, THE CHAIR CAME AWAY FROM THE CHASSIS AND FELL JUST AS THE WHEELS TOUCHED THE FLOOR. CHAIR AND PT FELL OFF CHASSIS. NO REPORTED INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBULIFT PASSIVE FLOOR LIFT FSA ARJO HOSPITAL EQUIPMENT AB AA0550-06

    Patients

    Seq Age Sex Outcome Treatment
    1 Other