BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA PPP

    MDR report key: 358570 · Received October 30, 2001

    Report

    Report Number
    9617021-2001-00165
    Event Type
    Malfunction
    Date Received
    October 30, 2001
    Date of Event
    August 31, 2001
    Report Date
    September 10, 2001
    Manufacturer
    ARJO LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS AS THE HOIST WAS BEING LOWERED WITH THE HANDSET, IT DID NOT STOP LOWERING AS THE DOWN BUTTON WAS RELEASED. IT WOULD NOT GO UP WITH THE UP BUTTON, AND THE EMERGENCY STOP BUTTON DID NOT FUNCTION. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48600 OPERA PPP PATIENT LIFT FSA ARJO LTD. KKBXXXX *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN