BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR

    MDR report key: 6090894 · Received November 9, 2016

    Report

    Report Number
    3006697299-2016-00201
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Report Date
    October 17, 2016
    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 ON 11/30/2016. -DEVICE HISTORY REVIEW, -TREND ANALYSIS, -FAILURE ANALYSIS. THE DEVICE HISTORY REVIEW VERIFIED NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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. TRENDING ANALYSIS: A REVIEW OF THE CUSTOMER COMPLAINTS WAS COMPETED USING THE FOLLOWING KEY WORDS ¿CATHETER FAILURE¿ AND A ROOT CAUSE ¿ICP FLEX CABLE¿ IN THE SEARCH CRITERIA. THE REVIEW ENCOMPASSED DATES 20-OCT-2015 TO 29-NOV-2016. THIS IS THE ONLY COMPLAINT OCCURRENCE WHICH CONTAINED THE SEARCH CRITERIA. (B)(4). THE FAILURE ANALYSIS EVALUATION VERIFIED THE COMPLAINT AS VALID. THE SERVICE CENTRE VERIFIED THE CATHETER FAILURE OCCURRED DUE TO A DEFECTIVE ICP FLEX CABLE ASSEMBLY. THE CAM02 MONITOR RECEIVED A REPLACEMENT ICP FLEX CABLE ASSEMBLY, WAS CALIBRATED AND SAFETY TESTED. THE RESULTS WERE REVIEWED AS PART OF THIS EVALUATION, ALL THE FUNCTIONALITY TESTS WERE CARRIED OUT ACCORDINGLY AND ALL RESULTS OF THE TESTS WERE RECORDED AS WITHIN SPECIFICATION. THE EVALUATION VERIFIED THE COMPLAINT AS VALID; THE CAUSE OF THE COMPLAINT ISSUE WAS IDENTIFIED AS A DEFECTIVE ICP FLEX CABLE ASSEMBLY. BASED ON THE COMPLAINT INVESTIGATION COMPLETED IT CAN BE CONCLUDED NO FURTHER EVALUATION IS REQUIRED. FUTURE COMPLAINTS WILL BE CONTINUED TO BE MONITORED AND TRENDED. CONCLUSION: THE EVALUATION VERIFIED THE COMPLAINT AS VALID; THE CAUSE OF THE COMPLAINT ISSUE WAS IDENTIFIED AS A DEFECTIVE ICP FLEX CABLE ASSEMBLY WHICH RESULTED IN A CATHETER FAILURE.

    Description of Event or Problem · 1

    THE CAM02 INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR EXPERIENCED A CATHETER FAILURE. THE DATE OF THE INCIDENT WAS NOT PROVIDED. THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT AND THERE WAS NO INJURY, NO DEATH ALLEGED, NO REVISION OR MEDICAL INTERVENTION AND THE PATIENT WAS NOT PREPPED FOR SURGERY. IT WAS UNKNOWN IF THERE WAS A DELAY IN SURGERY DUE TO THE PRODUCT PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742518 INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR ICP MONITORING GWM INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1