BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYER LIFT

    MDR report key: 823450 · Received January 31, 2007

    Report

    Report Number
    2182305-2006-00044
    Event Type
    Malfunction
    Date Received
    January 31, 2007
    Date of Event
    November 27, 2006
    Report Date
    December 8, 2006
    Manufacturer
    IMS, INC. INTEGRATED MEASUREMENT SYSTEM
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER, BY FACILITY. PER FACILITY, LIFT WAS BEING USED WHEN THE CRADLE / SCALE ASSEMBLY SEEMED TO BE BROKEN BETWEEN THE SCALE AND CRADLE. FACILITY IS NOT AWARE OF ANY INJURY. INCIDENT OCCURRED, MAINTENANCE MAN CAME TO WORK AND FOUND THE PARTS LYING ON HIS DESK. MANUFACTURER HAS REQUESTED A BETTER DESCRIPTION OF THE ALLEGED INCIDENT. THIS DEVICE HAS BEEN ISSUED TO HAVE PARTS 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 STATURE W/ SCALE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other