BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBDURAL POST CRANIOTOMY ICP MONITORING KIT

    MDR report key: 3971190 · Received April 29, 2014

    Report

    Report Number
    2023988-2014-00016
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 5, 2014
    Manufacturer
    INTEGRA NEURO SCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K853864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PATIENT HAD A 1104G PROBE INSERTED ON (B)(6) 2014, POST CRANIOTOMY. WITHIN 24 HOURS OF INSERTION, ON (B)(6) 2014, THE PROBE WAS SHOWING NEGATIVE 6 VALUES FOLLOWING THE PATIENT BEING REPOSITIONED IN THE BED. THE PATIENT DOES HAVE A WOUND DRAIN IN SITU BUT NO RECENT DRAIN MANIPULATIONS WERE REPORTED. THE INTRACRANIAL PRESSURE (ICP) WAS READING OKAY PRIOR TO PATIENT REPOSITIONING ALTHOUGH THE EXACT VALUES ARE NOT CURRENTLY AVAILABLE. NO OTHER CLINICAL CHANGES WERE REPORTED. THE CAMINO MONITOR AND CABLES WERE CHANGED TO NO AVAIL, NO ICP READING FROM THE MONITOR. THE CATHETER HAD BEEN WORKING WELL WITH A VISIBLE WAVEFORM THE DAY BEFORE THE EVENT OCCURRED. THE PATIENT ICP MONITORING WAS NOT CONSIDERED A CLINICAL PRIORITY AT THE TIME. THE REPRESENTATIVE WAS CONTACTED AND CHECKED THE UNITS ON (B)(6) 2014, NO ICP READING FROM THE MONITOR, ALL CONNECTIONS WERE CHECKED AND THE CAMINO MONITOR AND CABLES WERE CHANGED, STILL NO READING. NO NEW PROBE WAS REPLACED, A REPLACEMENT, WAS SUGGESTED BUT, (AS STATED BY THE REPRESENTATIVE) "I THINK THE CLINICAL DECISION WAS ALREADY MADE NOT TO INSERT A NEW PROBE ON THE GROUNDS THAT THE PATIENT PROGNOSIS WAS VERY POOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256309 SUBDURAL POST CRANIOTOMY ICP MONITORING KIT GWM INTEGRA NEURO SCIENCES CA/USA 30500X282007

    Patients

    Seq Age Sex Outcome Treatment
    1