BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT HELPER FRAME HILL-ROM

    MDR report key: 1172711 · Received September 19, 2008

    Report

    Report Number
    1035617-2008-00011
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    ILZ
    Removal / Correction Number
    1526350-07/03/2008-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. ZIMMER OSP CONTACTED RISK MANAGER AT ACCOUNT TO GATHER ADDITIONAL DETAILS OF THE EVENT. RISK MANAGER STATED THAT THE HOSPITAL HAD MODIFIED THE DEVICE BECAUSE THE PATIENT HELPER BAR SLID DOWN THE ADAPTOR TUBE AND THE TRAPEZE BAR CAME IN CONTACT WITH THE PATIENT'S HEAD, NO INJURY REPORTED. ZIMMER STATED THAT THE DEVICE IS CURRENTLY UNDER RECALL AND THE DEVICE SHOULD BE RETURNED.

    Description of Event or Problem · 1

    ACCOUNT STATES THAT THE PATIENT HELPER, WHEN LOOSENED, SLID DOWN THE ADAPTOR TUBE AND THE TRAPEZE BAR CAME IN CONTACT WITH THE PATIENT'S HEAD. NO PATIENT INJURY OR MEDICAL CARE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT HELPER FRAME HILL-ROM PATIENT HELPER FRAME HILL-ROM ILZ ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1