BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBDURAL POST CRANIOTOMY ICP MONITORING KIT

    MDR report key: 4156498 · Received October 7, 2014

    Report

    Report Number
    2023988-2014-00049
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 10, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES CA.USA
    Product Code
    GWM
    PMA / PMN Number
    K102875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 INFO.

    Description of Event or Problem · 1

    CROSS REFERENCE WITH MFR 8010219-2014-00051 ((B)(4)). DURING AN OPERATION, THE SURGEON INSERTED A 1104G BUT, THE CAM01 MONITOR DISPLAYED THE LOGO OF "CHECK CATHETER CONNECTION." HE TURNED THE CAM01 ON AND OFF AND PLUGGED THE CATHETER IN AND OUT. THAT WORKED AND THE SURGEON COULD ZERO IT BUT WHEN HE INSERTED THE CATHETER AGAIN IN THE INTENSIVE CARE UNIT (ICU) AFTER SURGERY, THE SAME PHENOMENON OCCURRED AGAIN. HE THEN PLUGGED IT IN AND OUT BUT THIS TIME, HE SAW AN "ERROR CODE 4" AND THE WRENCH MARK ON THE CAM01 DISPLAY. THE DISPLAYS DISAPPEARED BY EXCHANGING THE CATHETER AND WITH THE NEW CATHETER. THERE WAS A 20 MIN DELAY BECAUSE OF THE ISSUE. THE PT DID NOT INCUR AN INJURY AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626310 SUBDURAL POST CRANIOTOMY ICP MONITORING KIT NA GWM INTEGRA NEUROSCIENCES CA.USA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR