BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-FLEX HEAD POSITIONING SYSTEM

    MDR report key: 6749915 · Received July 28, 2017

    Report

    Report Number
    6749915
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    July 11, 2017
    Report Date
    July 24, 2017
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS BEING PREPARED FOR PRONE POSITION. THE MD WAS CHECKING THE C PRONE HEADREST FOR STABILITY WHEN THE CHIN REST BROKE OFF BEFORE THE PATIENT WAS TURNED FROM SUPINE TO PRONE. THIS WAS RECOGNIZED IMMEDIATELY AND REMOVED FROM SERVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530080 C-FLEX HEAD POSITIONING SYSTEM SUPPORT, PATIENT POSITION CCX ALLEN MEDICAL SYSTEMS, INC. A-70300-A3

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR NO OTHER THERAPIES| NOT FOR THIS PATIENT