BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACRANIAL PRESSURE/TEMPERATURE MONITORING K

    MDR report key: 3190668 · Received June 24, 2013

    Report

    Report Number
    2023988-2013-00013
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    January 14, 2013
    Report Date
    June 24, 2013
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K962928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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

    IT WAS REPORTED THAT THE CATHETER WOULD NOT CALIBRATE TO ZERO. ANOTHER CATHETER WAS USED. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS RECEIVED ON (B)(6) 2013: THE PRODUCT PROBLEM WAS FOUND BEFORE BEING USED ON THE PATIENT, DURING THE CALIBRATION TO ZERO. PATIENT IS A (B)(6) YEAR OLD FEMALE. TYPE OF PROCEDURE WAS MEASUREMENT PIC FOR TRAUMA CRANEOENCEFALICO. THERE WAS NO HARM OR INJURY TO THE PATIENT. THE DOCTOR ONLY CHANGED IT FOR A NEW CATHETER. THERE WAS A DELAY IN THE SURGERY/PROCEDURE OF 10 MINUTES 'WHEN THE DOCTOR GOT A CATHETER INTERNALLY FOR THE REPLACEMENT'. THE REPLACEMENT CATHETER WORKED. PATIENT OUTCOME WAS POSITIVE. RECOVERY WAS ACHIEVED WITH THE SUPPORT OF ICP MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285271 INTRACRANIAL PRESSURE/TEMPERATURE MONITORING K NA GWM INTEGRA NEUROSCIENCES CA/USA 305000233812

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR