BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER LIFT

    MDR report key: 1396751 · Received March 20, 2009

    Report

    Report Number
    2182305-2009-00004
    Event Type
    Other
    Date Received
    March 20, 2009
    Date of Event
    January 26, 2009
    Report Date
    February 20, 2009
    Manufacturer
    IMS, INC., INTEGRATED MEASUREMENT SYSTEM
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO DISTRIBUTOR, BY A DSI FACILITY, (B)(4), PER FACILITY THEY WERE TRANSPORTING A RESIDENT FROM BED TO CHAIR, WHILE THE RESIDENT WAS IN MID AIR, THE SCALE DETACHED FROM THE CRADLE AND THE RESIDENT FELL. THERE WERE TWO C.N.A.'S PRESENT AND WERE ABLE TO CATCH THE RESIDENT IN THE AIR BEFORE SHE HIT THE GROUND SO, NO INJURIES WERE REPORTED. FACILITY SENT PICTURES OF THE FAILED COMPONENT PART. RMA #84004105 HAS BEEN ISSUED TO GET CRADLES AND SCALES BACK FOR EVALUATION. (B)(4). IN ADDITION THE MANUFACTURER OF THE SCALE HAS BEEN NOTIFIED. IMS SCALE RECALL NUMBER IS AS FOLLOWS: Z-0921-2007. THIS IS BEING REPORTED UNDER MALFUNCTION, WHICH COULD HAVE RESULTED IN SERIOUS INJURY OR DEATH AS DEFINED IN 21 CFR PART 803.0/803.5. DURING THE DISTRIBUTOR INVESTIGATION OF THIS COMPLAINT, IT WAS DISCOVERED THAT THE DEALER HAD NOT NOTIFIED THEIR CUSTOMER OF SAID RECALL, EVEN THOUGH MANUFACTURER NOTIFIED DEALER AND REQUESTED THEM TO DO THEIR PUT WITHIN THE RECALL PROCESS, THIS DID NOT HAPPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFT PATIENT LIFTER FSA IMS, INC., INTEGRATED MEASUREMENT SYSTEM PRESENCE W/ SCALE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other