BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN MEDICAL SYSTEMS

    MDR report key: 956268 · Received November 30, 2007

    Report

    Report Number
    1221538-2007-00005
    Event Type
    Malfunction
    Date Received
    November 30, 2007
    Date of Event
    November 7, 2007
    Report Date
    November 30, 2007
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Removal / Correction Number
    1221538-112707-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISASSEMBLY AND EVALUATION OF THE UNIT INDICATED TWO COMPONENTS: THE HOOK BELL CRANK AND THE LOWER PADDLE LEVER COMPONENTS EXHIBITED SHARP EDGES SIGNIFICANT ENOUGH TO IMPAIR FUNCTION. THE SHARP EDGES CREATED INTERFERENCE BETWEEN COMPONENTS AND CAUSED THE FAILURE OF THE CONTROL MECHANISM FOR THE C-PRONE DEVICE.

    Description of Event or Problem · 1

    DURING AN INSERVICE TRAINING SESSION FOR THE C-FLEX HEAD POSITIONER, THE PRODUCT DEMONSTRATOR BECAME AWARE THAT THE UNIT WAS NOT LOCKING INTO POSITION PROPERLY. THE PROCEDURE FOR WHICH THE DEVICE TO BE USED IN, WAS RESCHEDULED. THERE WAS NO HUMAN INVOLVEMENT AS THE DEVICE WAS NOT IMPLEMENTED OR INVOLVED IN A PROCEDURE. THERE IS A POTENTIAL THAT THIS FAILURE MIGHT REQUIRE STAFF INTERVENTION TO PREVENT INJURY IF IT OCCURRED DURING A MEDICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS HEAD POSITIONER FWZ ALLEN MEDICAL SYSTEMS A-70700-A1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR