BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER LIFTER

    MDR report key: 1035024 · Received April 28, 2008

    Report

    Report Number
    2182305-2008-00009
    Event Type
    Other
    Date Received
    April 28, 2008
    Date of Event
    February 24, 2008
    Report Date
    February 29, 2008
    Manufacturer
    JOERNS HEALTHCARE, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR, BY DEALER, PER DEALER THEIR CUSTOMER, A HOME USER, WAS LIFTING HIS WIFE, SWIVELED HER TO PLACE HER IN THE CHAIR, WHEN SHE FELL TO THE FLOOR. A ROLL PIN CAME OUT OF THE NUT AND BOLT THAT KEEPS THE SPREADER BAR ATTACHED TO THE BOOM [THE ROLL PIN WAS NOT THERE AND COULD NOT BE LOCATED). WIFE WAS TAKEN TO THE ER BY AMBULANCE FOR MEDICAL EXAM, AND RETURNED HOME THE SAME DAY. BRUISES NOTED. SERIAL NUMBER OF THE LIFT INDICATES IT WAS MANUFACTURED 3/13/1993. THIS IS A 15 YEAR OLD LIFT, 10 YEARS OUT OF WARRANTY PERIOD AND STILL IN SERVICE. IN ADDITION, 7 YEARS AFTER THE DISCONTINUED DATE FOR THIS LIFT. DEALER HAS ALREADY FURNISHED HOME USER WITH A NEW LIFT. NO EVIDENCE OF PROPER MAINTENANCE PROVIDED BY DEALER TO MFR. RMA ISSUED TO GET LIFT IN QUESTION BACK FOR EVALUATION AND TO GET A 15-YEAR OLD PRODUCT OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFTER PATIENT LIFTER FSA JOERNS HEALTHCARE, INC. TRANS AID

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other