BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA PPP

    MDR report key: 422296 · Received October 14, 2002

    Report

    Report Number
    9617021-2002-00202
    Event Type
    Malfunction
    Date Received
    October 14, 2002
    Date of Event
    October 8, 2002
    Report Date
    October 14, 2002
    Manufacturer
    ARJO LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS WHEN STARTING THE TRANSFER BOTH THE PT AND THE CARER HEARD SOMETHING CRACK. THE CARER CONTINUED THE TRANSFER. LATER THERE WAS FOUND TO BE A LOT OF TOLERANCE ON THE ARM. THE FACILITY FIRST CALLED THEIR OWN TECHNICAL SERVICE, WHO CHECKED THE LIFT AND FOUND THE BOLTS HAD BROKEN OFF. NO INJURIES WERE REPORTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTS WHEN STARTING THE TRANSFER BOTH THE PT AND THE CARER HEARD SOMETHING CRACK. THE CARER CONTINUED THE TRANSFER. LATER THERE WAS FOUND TO BE A LOT OF TOLERANCE ON THE ARM. THE FACILITY FIRST CALLED THEIR OWN TECHNICAL SERVICES, WHO CHECKED THE LIFT AND FOUND THE BOLTS HA BROKEN OFF. 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