BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA

    MDR report key: 2434081 · Received January 23, 2012

    Report

    Report Number
    9681684-2012-00004
    Event Type
    Malfunction
    Date Received
    January 23, 2012
    Date of Event
    December 28, 2011
    Report Date
    December 29, 2011
    Manufacturer
    ARJO MED AB, LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY (B)(4), ON BEHALF OF THE MFR (B)(4). PLEASE NOTE THAT WHILE THIS PRODUCT IS NO LONGER MANUFACTURED, PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE (B)(4) MED. AB LTD. AS OF (B)(6) 2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY BHM MEDICAL INC. THE EVALUATION OF THE DEVICE TO DATE HAS BEEN CARRIED OUT BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    THE CAREGIVERS WERE TRANSFERRING A RESIDENT FROM A BED TO A CHAIR USING A FLOOR LIFT. THEY LIFTED UP THE RESIDENT APPROX 4 INCHES ABOVE THE BED AND THEN THE SPREADER BAR FELL FROM THE LIFT AND THE RESIDENT DROPPED BACK TO THE BED. THE SPREADER BAR LANDED ON RESIDENT UPPER BODY. NO INJURIES WERE SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERA MANUFACTURED FLOOR PASSIVE LIFT FSA ARJO MED AB, LTD. KPA0300

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other