BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR

    MDR report key: 6300187 · Received February 3, 2017

    Report

    Report Number
    3006697299-2017-00019
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Report Date
    January 20, 2017
    Manufacturer
    INTEGRA LIFESCIENCES(IRELAND)
    Product Code
    GWM
    PMA / PMN Number
    K121573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 5/30/17. METHOD: DEVICE HISTORY REVIEW. TREND ANALYSIS. FAILURE ANALYSIS. THE DHR REVIEW WAS COMPLETED FOR CAM02 MONITOR SERIAL NUMBER (B)(4). THE DHR REVIEW VERIFIED NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. ALL THE FUNCTIONALITY TESTS WERE CARRIED OUT ACCORDINGLY AND ALL RESULTS OF THE TESTS WERE RECORDED AS WITHIN SPECIFICATION PRIOR TO THE CAM02 MONITOR BEEN RELEASED. DATE OF MANUFACTURE: 2013- MAY. SERVICE HISTORY REVIEW: THE SERVICE HISTORY REVIEW VERIFIED NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. A REVIEW OF THE CUSTOMER COMPLAINTS WAS COMPETED USING THE FOLLOWING KEY WORDS ¿READING HIGH VALUES¿ IN THE SEARCH CRITERIA. THE REVIEW ENCOMPASSED DATES 27-JAN-16 TO 21-FEB -17. THERE WERE 11 COMPLAINTS WHICH CONTAINED THE SEARCH CRITERIA. THE REVIEW VERIFIED THIS COMPLAINT IS THE SINGLE COMPLAINT OCCURRENCE FOR SERIAL NUMBER (B)(4). RATE OF OCCURRENCE: DURING THE TIME PERIOD ¿JAN 16 TO FEB 17¿, THE GLOBAL PRODUCT USAGE FOR CAM02 MONITORS COMBINED WAS CALCULATED AS (B)(4) USAGES, USING THE TOTAL QUANTITY OF CAM02 MONITOR CATHETER SALES SOLD TO CALCULATE THE QUANTITY OF USAGES. 1 CATHETER IS USED PER PROCEDURE, AND IS USED AS A MEANS OF QUANTIFYING THE NUMBER OF PROCEDURES UNDERTAKEN. THE QUANTITY OF COMPLAINTS IN THE COMPLAINT REVIEW (11) CAN THEREFORE BE CALCULATED AS (B)(4) (OCCASIONAL) OF PROCEDURES. CONCLUSION: PRODUCT WAS NOT RETURNED FOR EVALUATION AFTER SEVERAL DOCUMENTED ATTEMPTS. THEREFORE, WE ARE UNABLE TO DETERMINE ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 1

    FOUR PATIENTS PRESENTED WITH VERY HIGH INTRACRANIAL PRESSURE (ICP) READINGS (60-80MMHG) POST IMPLANTATION. THESE READING WERE NOT ACCEPTED BY THE NEUROSURGEONS. THE PATIENTS WERE SENT FOR CT SCAN/MAGNETIC RESONANCE IMAGING AND APPEARED TO HAVE "PLENTY OF SPACE". UPON REMOVAL, ONE OF THE 110-4B CATHETERS WAS FOUND TO BE "BENT". THE ISSUE INCREASED THE TIME FOR FOLLOWING PATIENT PRESSURE. ADDITIONAL INFORMATION RECEIVED ON 24JAN2017 WITH THE FOLLOWING: THE MONITOR WAS CHANGED MULTIPLE TIMES FOR THE FOUR PATIENTS WHO HAD THE CATHETER PLACED DUE TO HEAD TRAUMA BUT THE ICP READING WAS STILL ELEVATED. NO PATIENT INJURY WAS REPORTED. AS A PRECAUTION, ALL 8 OF THE CUSTOMER'S CAM02 MONITORS WILL BE SENT TO THE MANUFACTURER FOR EVALUATION. LINKED TO MFG. REPORT NUMBERS: 2023988-2017-00005, 2023988-2017-00006, 2023988-2017-00007, 2023988-2017-00008, 3006697299-2017-00018, 3006697299-2017-00024, 3006697299-2017-00020, 3006697299-2017-00021, 3006697299-2017-00022, 3006697299-2017-00023, 3006697299-2017-00025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82419 INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR ICP MONITORING GWM INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1