BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFTING POLE & HANDLE ASSY

    MDR report key: 1934178 · Received December 8, 2010

    Report

    Report Number
    3003984900-2010-00013
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ARJOHUNTLEIGH
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS CLEAR THAT THE HOUSING HAS FAILED, THE MANNER IN WHICH IT HAS FAILED IS NOT CLEAR; THEREFORE WE HAVE REQUESTED THE PART FOR A CLOSER EXAMINATION. WE WILL SUBMIT A F/U REPORT IN DUE COURSE GIVING DETAILS OF OUR FINDINGS AND ACTIONS.

    Description of Event or Problem · 1

    WE HAVE REC'D A REPORT FROM OUR (B)(4) SUBSIDIARY THAT A CUSTOMER (B)(6) HAS REPORTED THAT THE VAN RIESEN STRAP & HANDLE THAT WE SUPPLY AS PART OF THE BED ACCESSORY (B)(4) LIFTING POLE & HANDLE ASSY HAS BROKEN ON THE ADJUSTABLE STRAP HOUSING, THE BREAKAGE OCCURRED WHEN THE PT WANTED TO SIT-UP AND PULLED ON THE HAND GRIP. CLIENT FELL BACK INTO THE BED. ALTHOUGH NO INJURY WAS SUSTAINED WE ARE REPORTING THE INCIDENT BECAUSE OF A POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFTING POLE & HANDLE ASSY BED ACCESSORY FNL ARJOHUNTLEIGH ENT-ACC01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other