BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER

    MDR report key: 8615207 · Received May 16, 2019

    Report

    Report Number
    9612007-2019-00027
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 23, 2019
    Report Date
    April 24, 2019
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    GWM
    PMA / PMN Number
    K040235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED A MARK AT THE LEVEL OF THE ACTIVE AREA, AND A DEFORMED CATHODE. THE LICOX PROBE WAS CONNECTED TO THE MONITOR AND DISPLAYED AN OXYGEN PRESSURE VALUE OF AROUND 450MMHG, DECREASING UNTIL AROUND 135MMHG (NORMAL OPERATION). MANIPULATIONS OF THE CABLE LINKING THE PROBE TO THE MONITOR AT THE LEVEL OF THE WHITE CONNECTORS (PROBE/CABLE CONNECTORS) LED TO LOSE THE SIGNAL (0 MMHG). WHEN REPLACING CONNECTORS ON THE TABLE, SIGNAL CAME BACK. A SLIGHT GAP WAS NOTED BETWEEN MALE PINS OF THE PROBE CONNECTOR AND FEMALE PINS OF THE CABLE CONNECTOR: THIS MAY EXPLAIN THE ISSUE; AS THE CONNECTOR¿S PRINTED CIRCUIT BOARD AND ELECTRICAL LINKS ARE EMBEDDED IN SILICONE, IT CANNOT BE DISMANTLED. THE DEVICE HISTORY RECORDS REVIEW OF REF IP2P, LOT 210945, SN (B)(4) DID NOT REVEAL ANY ANOMALY THAT COULD EXPLAIN THE REPORTED EVENT. THE REPORTED COMPLAINT WAS CONFIRMED. THE EXACT ROOT CAUSE OF THIS PROBLEM COULD NOT BE DETERMINED. DEVICE IDENTIFIER IP2P: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A TERRITORY MANAGER REPORTED ON BEHALF OF THE CUSTOMER THAT A PATIENT HAD AN IP2P (LICOX CATHETER KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER) IN PLACE FOR 24 HOURS. IT WAS NOTED THAT THE LICOX MONITOR PTO2 AND THE TEMPERATURE VALUE ON SCREEN CHANGED WHEN THE NURSE MANIPULATED THE WHITE CONNECTOR OF THE BLUE CABLE AND THE CONNECTOR CC1. P1 OF THE IP2P CATHETER ON (B)(6) 2019. IT WAS AN INTERMITTENT SITUATION WHEN THE NURSE TOUCHED THE CABLE AND THE CATHETER WAS NOT MANIPULATED. THE MONITOR HAD BEEN VERIFIED WITH THE WHITE CONNECTOR TEST AND THE GREEN CARD TEST. THE MONITOR WAS WORKING WELL, VALUE AT 154, AND TEMPERATURE AT 22C. NO PATIENT INJURY OR DEATH WAS ALLEGED AND NO REVISION OR MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411470 KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER LICOX BOLTS CATHETERS & KITS GWM INTEGRA NEUROSCICENCS IMPLANTS SA 210945

    Patients

    Seq Age Sex Outcome Treatment
    1