BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYER LIFT

    MDR report key: 823428 · Received January 31, 2007

    Report

    Report Number
    2182305-2006-00047
    Event Type
    Malfunction
    Date Received
    January 31, 2007
    Date of Event
    September 21, 2006
    Report Date
    December 22, 2006
    Manufacturer
    IMS, INC. INTEGRATED MEASUREMENT SYSTEM
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER, BY FACILITY, ANOTHER COUNTRY NURSING CENTER, THAT THE FACILITY WAS WEIGHTING RESIDENTS, THE AIDE CAME BACK IN THE ROOM AND FOUND SCALE AND 4PT CRADLE LYING ON THE FLOOR. STATED THAT THE SCALE SHAFT BROKE RIGHT AT THE SCALE TOP. NO PATIENT IN THE LIFT AT THE TIME, PREVIOUS PERSON WEIGHED WAS 155 LBS. THIS DEVICE HAS BEEN ISSUED TO HAVE PRODUCT RETURNED FOR EVALUATION. IN ADDITION, THE MANUFACTURER OF SCALE HAS BEEN NOTIFIED. THIS IS BEING REPORTED UNDER MALFUNCTION, WHICH COULD HAVE RESULTED IN SERIOUS INJURY OR DEATH AS DEFINED IN 21 CFR PART 803.3 / 803.5.

    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 YR Other