BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA PPP

    MDR report key: 425666 · Received October 31, 2002

    Report

    Report Number
    9617021-2002-00183
    Event Type
    Malfunction
    Date Received
    October 31, 2002
    Date of Event
    August 23, 2002
    Report Date
    September 9, 2002
    Manufacturer
    ARJO, LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE PATIENT WAS BEING TRANSFERRED WITH A HOIST. THE CAREGIVER DID NOT SECURE ONE CLIP TO THE HOIST. THE CARER LIFTED THE PT FROM THE WHEELCHAIR WHILE ONE CLIP WAS NOT SECURED BY TOUCHING THE ARMREST THAT HAD BEEN TURNED. THE CARER HAD REMOVED THE WHEELCHAIR TO BRING THE HOIST INTO THE RIGHT POSITION. AS THEY PUSHED IT FORWARDS, THE UNSECURED CLIP DETACHED. THE PT FELL OUT OF THE SLING ONTO THE FLOOR, SUFFERING A LUMP ON THE HEAD, BRUISES TO THE BODY, AND A POSSIBLE CONCUSSION.

    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 Other