BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2142594 · Received June 21, 2011

    Report

    Report Number
    1525712-2011-00269
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 2, 2011
    Report Date
    June 20, 2011
    Manufacturer
    INVACARE
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED.

    Description of Event or Problem · 1

    THE FACILITY STATES THE RESIDENT WAS BEING TRANSFERRED FROM THE BED TO A WHEELCHAIR, WHEN THE SPREADER BAR ALLEGEDLY DETACHED FROM THE FLOOR LIFT BEFORE THE RESIDENT REACHED THE WHEELCHAIR, RESULTING IN THE RESIDENT BEING DROPPED TO THE FLOOR. THE FACILITY ALLEGES THE SET SCREW IS MISSING FROM THE SCALE AND COULD NOT BE FOUND IN THE ROOM. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE FSA INVACARE RPA600-1

    Patients

    Seq Age Sex Outcome Treatment
    1