BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA PPP

    MDR report key: 408362 · Received July 31, 2002

    Report

    Report Number
    9617021-2002-00094
    Event Type
    Malfunction
    Date Received
    July 31, 2002
    Date of Event
    April 10, 2002
    Report Date
    May 8, 2002
    Manufacturer
    ARJO, LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS THAT AS STAFF WERE INSTALLING SLING (ATTACHING THE CLIPS TO THE JIB), THE JIB CAME OFF AND FELL ON THE RESIDENT'S LEGS. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERA PPP PATIENT LIFT FSA ARJO, LTD. KPBXXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN