BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA PPP

    MDR report key: 390202 · Received April 23, 2002

    Report

    Report Number
    9617021-2002-00072
    Event Type
    Malfunction
    Date Received
    April 23, 2002
    Date of Event
    March 26, 2002
    Report Date
    April 5, 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 THE NURSES WERE LIFTING A PATIENT ONTO A TABLE. AFTER RELEASING THE DOWN BUTTON ON THE HANDSET THE LIFT WAS WORKING ON ITS OWN. DURING THE LOWERING OF THE LIFT ITSELF THE NURSES RELEASED THE SLING AND PULLED THE LIFT AWAY FROM THE TABLE. THE LIFT WAS LOWERING INTO THE LOWEST POSITION. AFTER THIS, THE LIFTER DID NOT WORK ANYMORE. WHEN THE SERVICE ENGINEER VISITED, THE LIFTER WAS IN ITS LOWEST POSITION WITH THE LEFT LIFT STRAP TWISTED. THE AUTOMATIC FUSES WORKED. AFTER RESETTING, THE "PPP" WORKED NORMALLY, BUT THE OTHER FUNCTIONS DID NOT WORK. THE CUSTOMER SMELLED SMOKE. THE ACTUATOR WOULD GO UP OR DOWN, BUT STOPPED IMMEDIATELY AND WAS IN ITS LOWEST POSITION THROUGH THE LOWERING SWITCH. THE ACTUATOR WAS RELEASED AND THE LIFTER ASSEMBLED. THE LIFTER DID NOT GO UP AND DOWN, THE LEGS WERE NOT WORKING, AND THE PRINTBOARD WAS ALSO BROKEN. A NEW PRINTBOARD WAS FITTED AND THE LIFTER WORKED AGAIN.

    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 2 YR