BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA

    MDR report key: 1930248 · Received November 18, 2010

    Report

    Report Number
    9681684-2010-00049
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 16, 2010
    Report Date
    October 20, 2010
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    TWO STAFF MEMBERS WERE TRANSFERRING A RESIDENT FROM A WHEELCHAIR TO A BED. AT THE MOMENT WHEN THE LEGS OF THE LIFT WERE MOVING UNDER THE BED, THE LIFT BEGAN TO TILT TO THE SIDE. AS THE LIFT CONTINUED TO TILT AND FALL, THE STAFF MEMBERS GUIDED RESIDENT OVER THE BED AND WERE ABLE TO PREVENT RESIDENT FROM HITTING FLOOR. NO INJURIES FOR THE RESIDENT WERE REPORTED BUT A STAFF MEMBER SUSTAINED A SPRAINED BACK, SHOULDER AND CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERA LIFT, PATIENT, NON-AC POWERED FSA BHM MEDICAL, INC. KPB3000-21US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other