BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE PARAMETER ICP MONITOR

    MDR report key: 4260976 · Received October 30, 2014

    Report

    Report Number
    8010219-2014-00054
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Product Code
    GWM
    PMA / PMN Number
    K031086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS REPORT IS IN REGARD TO THE SPM1 (SINGLE PARAMETER ICP MONITOR). THE CUSTOMER REPORTED THAT A B BOLT WAS PLACED INTO A TBI (TRAUMATIC BRAIN INJURY) PATIENT AND READ AN INTRACRANIAL PRESSURE (ICP) OF 17. HOWEVER, ATER DISCONNECTING THE PROBE FROM THE MONITOR CABLE AND RECONNECTING THE SAME MONITOR, IT SHOWED A NEGATIVE ICP VALUE AND THEN AFTER 2 HOURS, IT SHOWED AN ICP READING OF 7MMHG. THIS WAS NO BELIEVED TO FIT WITH THE CLINICAL PICTURE. THE RED DEPTH INDICATOR WAS REPORTED TO BE IN THE CORRECT POSITION. TROUBLE-SHOOTING WAS LIMITED AS THERE WAS NO OPPORTUNITY TO CONNECT THIS SPM INTO THE BEDSIDE TO CHECK THE WAVEFORM AND NO OPTION TO SWITCH TO ANOTHER MONITOR AS NO ALTERNATIVE WAS AVAILABLE. IT WAS NOT KNOWN WHETHER THE READINGS CHANGED WHEN THE PATIENT WAS STIMULATED OR WHETHER A WOUND DRAIN ON SUCTION OR AN EVD (EXTERNAL VENTRICULAR DRAIN) WAS PRESENT. IT WAS UNKNOWN IF THE PATIENT WAS INJURED OR IF THE EVENT LED TO AN INCREASE IN THE SURGERY TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694719 SINGLE PARAMETER ICP MONITOR NA GWM INTEGRA NEUROSCIENCES, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1