BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT POSITION SUPPORT

    MDR report key: 1501759 · Received September 12, 2009

    Report

    Report Number
    1641643-2009-00001
    Event Type
    Malfunction
    Date Received
    September 12, 2009
    Date of Event
    August 3, 2009
    Report Date
    September 11, 2009
    Manufacturer
    MCCONNELL ORTHOPEDIC MFG. CO.
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PT WAS NOT INVOLVED WITH THIS USER CAUSED MALFUNCTION. THE HEALTH CARE PROFESSIONAL INVOLVED MADE THE DECISION NOT TO USE THIS DEVICE AS PRESENTED BY THE HOSP. A NEW UNIT WAS IMMEDIATELY SENT TO THE HOSP UPON THEIR REQUEST AND THE INTENTIONS OF MCCONNELL.

    Description of Event or Problem · 1

    THIS WAS REPORTED TO MCCONNELL ORTHOPEDIC MFG (MCCONNELL) ON (B)(6) 2009. THE PHYSICIAN WAS IN THE PROCESS OF POSITIONING THE HEADREST AND IT WOULD NOT MOVE FROM SIDE TO SIDE AS INDICATED. THE PHYSICIAN INDICATED THAT THE METAL HEADREST APPEARED TO BE WELDED THUSLY PREVENTING SIDE-TO-SIDE MOVEMENT (OR ANY MOVEMENT). THE HEADREST IS DESIGNED TO BE ADJUSTED FOR INDIVIDUAL PT REQUIREMENTS, E.G. VARYING SIZES OF PTS. THE HEADREST WAS APPARENTLY WELDED BY SOMEONE AT THE HOSP AFTER THE MEDICAL DEVICE WAS RECEIVED FOR USE. IT SHOULD BE NOTED THAT THIS WELDING ACTIVITY IS NOT PART OF THE ORIGINAL, RELEASED DEVICE (FROM MCCONNELL) NOR WAS THIS TYPE OF ACTIVITY SANCTIONED OR CONDONED BY MCCONNELL VERBALLY OR VIA DOCUMENTED DIRECTION. AN INTERNAL COMPLAINT FORM WAS FILLED OUT BY MCCONNELL ON (B)(4) 2009 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT POSITION SUPPORT PATIENT POSITION SUPPORT - HEADREST CCX MCCONNELL ORTHOPEDIC MFG. CO. HEADREST NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA