BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBRE OPTIC CTETER CABLE

    MDR report key: 4172276 · Received October 9, 2014

    Report

    Report Number
    3006697299-2014-00111
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    July 3, 2014
    Report Date
    September 17, 2014
    Manufacturer
    INTEGRA LIFESCIENCES IRELAND LIMITED
    Product Code
    GWM
    PMA / PMN Number
    K121573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CROSS REFERENCE WITH MFR. NUMBERS 3006697299-2014-00079 ((B)(4)) AND 3006697299-2014-00080 ((B)(4)). IT WAS CONFIRMED THAT THE SAME CAM CABLE WAS USED ON TWO DIFFERENT MONITORS WHEN THE OPENING READING WAS 129MMHG AFTER ZEROING. THE UNIT WAS IN CONTACT WITH THE PATIENT. THE PROBE WAS CHANGED. THE PATIENT DID NOT SUSTAIN AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636909 FIBRE OPTIC CTETER CABLE ICP MONITORING GWM INTEGRA LIFESCIENCES IRELAND LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR