BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARENCHYMAL PRESSIO CATHETER

    MDR report key: 6921507 · Received October 6, 2017

    Report

    Report Number
    3001587388-2017-17460
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    September 6, 2017
    Report Date
    December 12, 2017
    Manufacturer
    SOPHYSA SA
    Product Code
    GWM
    PMA / PMN Number
    K162108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPERTISE OF THE SUSPECTED MEDICAL DEVICE HAS NOT YET BEGUN AND WILL MAKE IT POSSIBLE TO KNOW THE REASONS OF THE COMPLAINT. HOWEVER ; INTERNAL DOCUMENTATION SHOWS THAT THE ICP PROBE HAS BEEN DELIVERED CONFORM TO ITS SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE INTERNAL DOCUMENTATION HAS BEEN REVIEWED AND SHOWS ANY PERFORMANCE ABNORMALITY OR ANY CAUSALITY RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE SUSPECTED DEVICE. A VISUAL ANALYSIS WAS PERFORMED AND SHOWED THAT THE RETURNED PROBE WAS CLEAN AND WITHOUT VISUAL DEFECT. A FUNCTIONAL ANALYSIS WAS THEN PERFORMED. ACCORDING TO THIS ANALYSIS, THE PROBE REACTS NORMALLY TO THE IMPOSED PRESSURE VARIATIONS. OUR QUALITY CONTROL DEPARTMENT WAS UNABLE TO REPRODUCE THE DEFECT OBSERVED BY THE USER AND THUS THE DEFECT CAN NOT BE CONFIRMED. IN CONCLUSION, THE PROBE DOES MEET ITS SPECIFICATIONS.

    Description of Event or Problem · 1

    AFTER 2 IMPLANTATION DAYS, ICP MONITOR SHOWED AN ABNORMAL VALUE (-3O MMHG). THEN THE SENSOR HAS BEEN EXPLANTED AND REPLACED. WITH REPLACED PROBE, THE ICP MONITOR DISPLAYED NORMAL VALUE.

    Description of Event or Problem · 1

    AFTER 2 IMPLANTATION DAYS, ICP MONITOR SHOWED AN ABNORMAL VALUE (-30MMHG). THEN THE SENSOR HAS BEEN EXPLANTED AND REPLACED. WITH REPLACED PROBE, THE ICP MONITOR DISPLAYED NORMAL VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705506 PARENCHYMAL PRESSIO CATHETER ICP PRESSURE MONITORING CATHETER GWM SOPHYSA SA ICP CATHETER D0574

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention