BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN MEDICAL SYSTEMS

    MDR report key: 1742573 · Received June 25, 2010

    Report

    Report Number
    1221538-2010-00004
    Event Type
    Malfunction
    Date Received
    June 25, 2010
    Date of Event
    May 27, 2010
    Report Date
    May 27, 2010
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED POSITIONER WAS TESTED BY ENGINEERING UPON RETURN. THE UNIT FAILED WEIGHT PULL-TESTING AT THE SHOULDER JOINT. DISASSEMBLY CONFIRMED THAT NONE OF THE INTERNAL MECHANISMS HAD MOVED OR BEEN JARRED OUT OF PLACE DURING USE OR TRANSPORTATION. THE ONLY ISSUE IDENTIFIED DURING THE INVESTIGATION WAS THE IMPROPER ASSEMBLY OF THE WASHER STACKUP (INVERTED WASHER COMPONENTS) IN THE POSITIONER'S (B)(6) ASSEMBLY - WHICH REDUCED THE TRAVEL OF THE ASSEMBLY BY APPROXIMATELY ONE-THIRD AND COULD ACCOUNT FOR THE MALFUNCTION. A REVIEW OF THE POSITIONER'S DEVICE HISTORY INDICATES THAT ONLY ONE UNIT WAS MANUFACTURED DURING THE BUILD. THERE WAS NO PATIENT INVOLVEMENT AND NO MEDICAL EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, AN ALLEN REPRESENTATIVE CALLED TO REPORT THAT THE DEMO UNIT C-FLEX POLAR HEAD POSITIONER IN THEIR POSSESSION WAS NOT HOLDING POSITION PROPERLY. WHEN THE POSITIONER HANDLES ARE RELEASED, THE UNIT IS DESIGNED TO REMAIN IN A FIXED POSITION. THE DEMO UNIT NO LONGER FUNCTIONED APPROPRIATELY AND WHEN RELEASED, THE UNIT DESCENDED APPROXIMATELY 1-2CM BEFORE COMING TO A STOP. ONCE THE ISSUE WAS IDENTIFIED, THE POSITIONER WAS TAKEN OUT OF USE. THERE WAS NO PATIENT INVOLVEMENT.

    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