BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-FLEX POLAR HEAD POSITIONER

    MDR report key: 2913608 · Received January 8, 2013

    Report

    Report Number
    1221538-2013-00001
    Event Type
    Other
    Date Received
    January 8, 2013
    Report Date
    December 10, 2012
    Manufacturer
    ALLEN MEDICAL
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO INJURIES OR IMPACTS TO THE CASE REPORTED. THE C-FLEX WAS JUST REC¿D ON (B)(4) 2013 AND AN ENGINEERING INVESTIGATION IS NOW UNDERWAY. WHEN THE INVESTIGATION IS COMPLETED AND ROOT CAUSE HAS BEEN DETERMINED, A F/U REPORT WILL BE COMPLETED.

    Description of Event or Problem · 1

    DURING SETUP FOR A PT CASE, A C-FLEX HEAD POSITIONER WAS REPORTED TO NOT BE HOLDING POSITION. ACCORDING TO THE ALLEN REP WHO VISITED WITH THE STAFF, THE DOWNWARD MOVEMENT WAS PERCEIVED PRIOR TO THE START OF THE SURGERY. THE STAFF TOOK THE UNIT OUT OF USE AND USED A DIFFERENT POSITIONER TO COMPLETE THE CASE. NO IMPACTS, NO INJURIES AND NO SIGNIFICANT DELAYS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10398 C-FLEX POLAR HEAD POSITIONER C-FLEX, SURGICAL HEAD POSITIONER FWZ ALLEN MEDICAL A-70701-A2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1