BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA CAMINO ICP MONITOR

    MDR report key: 7641888 · Received June 27, 2018

    Report

    Report Number
    2023988-2018-00039
    Event Type
    Malfunction
    Date Received
    June 27, 2018
    Report Date
    June 13, 2023
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    GWM
    UDI-DI
    10381780039310
    PMA / PMN Number
    K121573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONTACT OFFICE- SECTION G1. MR. (B)(6) . NATUS MEDICAL INC. 5955 PACIFIC CENTER BLVD SAN DIEGO, CA. 92121, US. TELEPHONE: (B)(6) . FAX: ((B)(6) . EMAIL: (B)(6) .

    Additional Manufacturer Narrative · 0

    REFERENCE NATUS COMPLAINT# (B)(4). FOLLOW UP# 001 RE-SUBMITTED TODAY JUNE 13, 2023. THIS REPORT WAS ORGINALLY SUBMITTED IN ERROR ON SEPT 04, 2018 UNDER THE INCORRECT REPORTING YEAR 2023988-2019-00039. NATUS COMPLETED THEIR INVESTIGATION ON 29 AUGUST 2018. INVESTIGATION METHODS INCLUDED THE FOLLOWING: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY AND SERVICE HISTORY RECORDS. REVIEW OF COMPLIANT HISTORY/ COMPLAINT RATE. REVIEW OF PAST CAPAS/ CAPA HISTORY. RISK MANAGEMENT REVIEW. RESULTS: THE CUSTOMER'S COMPLAINT "NOT READING CORRECTLY/' WAS NOT CONFIRMED. THE UNIT WAS FUNCTIONALLY TESTED, VISUALLY INSPECTED AND THE ELECTRICAL SAFETY TEST PERFORMED, NO PROBLEMS WERE FOUND AND ALL TEST RESULTS MET SPECIFICATIONS. DHR REVIEW: THE DHR FOR THE MONITOR WAS REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT INCIDENT WERE OBSERVED. THE DEVICE WAS MANUFACTURED ON: SEP-2014. COMPLAINT HISTORY REVIEW/ TREND ANALYSIS: BASED ON THE COMPLAINT DESCRIPTION, SIMILAR INCIDENTS WITH A FAULT CODE OF INTEGRA- READING WERE SEARCHED DURING THE INVESTIGATION OF THE COMPLAINT HISTORY. THE REVIEW ENCOMPASSED DATES JUN-2016 THROUGH MAY-2018. THERE WERE SEVEN (7) CONFIRMED COMPLAINTS DURING THIS TIME. THESE RESULTS COUPLED WITH THE NUMBER OF SALES (JAN2016 TO APR-2018), 1795 UNITS, THE NUMBER OF CONFIRMED REPORTS (7) DIVIDED BY THE NUMBER OF UNITS SOLD, LOANER, RENTAL MODEL CAM02, CAM02RNT, CAM02LF IN JUN-2016 TO MAY-2018, (1795) AND MULTIPLIED BY 100 RESULTS IN A FAILURE RATE PERCENTAGE (B)(4). CAPA: A REVIEW OF CAPA'S INITIATED WITHIN THE PAST 24 MONTHS, CAPAS BOTH OPEN AND CLOSED WAS PERFORMED SPECIFICALLY RELATED TO THE COMPLAINT TO DETERMINE IF A SIMILAR COMPLAINT IS EITHER UNDER ACTIVE CAPA INVESTIGATION OR HAVE BEEN PREVIOUSLY ADDRESSED THROUGH A CAPA NO CAPA SCOPES DURING THE LAST 24 MONTHS ADDRESS ISSUES RELATED TO THIS CUSTOMER'S COMPLAINT. RISK MANAGEMENT REVIEW: A REVIEW OF THE CAM02 MEDICAL DEVICE HAZARD ANALYSIS (REV.L ) IDENTIFIES THE HAZARD FOR THE CUSTOMERS COMPLAINT" NOT READING CORRECTLY" AS "INCORRECT OR UNAVAILABLE ICP TREND DATA" (HAZARD ID # DIA-008). THE HARM BEING AN INCONVENIENCE TO USER WITH A SEVERITY OF NEGLIGIBLE. ROOT CAUSE: NO FAULT FOUND- DEVICE MET SPECIFICATIONS. THIS COMPLAINT IS NOW DEEMED CLOSED.

    Description of Event or Problem · 1

    CAM02 (B)(4) NOT READING CORRECTLY. ADDITIONAL INFORMATION RECEIVED VIA PHONE CALL ON 18 JUNE 2018: DEVICE WAS ATTACHED TO PATIENT AT THE TIME OF THE INCIDENT. NO INJURY TO THE PATIENT; DEVICE WAS CHANGED OUT; THERE WAS SOME DELAY IN SURGERY, BUT NOT A SIGNIFICANT ONE. INCIDENT DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483999 INTEGRA CAMINO ICP MONITOR INTRACRANIAL PRESSURE MONITORING DEVICE GWM INTEGRA LIFESCIENCES (IRELAND) LIMITED CAM02 10381780039310

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention