BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGAV SHUNTSYSTEM

    MDR report key: 7273436 · Received February 15, 2018

    Report

    Report Number
    3004721439-2018-00017
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 25, 2018
    Report Date
    September 5, 2019
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K103003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER). EXEMPTION NUMBER: E2017044. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 0

    THE VALVE WAS RETURNED IN A PLASTIC CONTAINER, DRY WITHOUT LIQUID. THE VALVE WAS AT PRESSURE LEVEL 18 CMH2O SET. A VISUAL INSPECTION WAS PERFORMED BUT THERE WERE NO DEFORMITIES OBSERVED. IN ORDER TO CHECK A POSSIBLE BLOCKAGE OF THE VALVE, WE PERFORMED A PERMEABILITY TEST. THIS TEST IS AT A HYDROSTATIC PRESSURE DIFFERENCE OF APPROXIMATELY 20 - 30 CMH2O IN FLOW DIRECTION CARRIED OUT. THE TEST SHOWED THAT THE VALVE IS NOT PERMEABLE. THE VALVE WAS ADJUSTED TO STEP UP AND DOWN ALL PRESSURE LEVELS IN 5-STEP INCREMENTS. THE INVESTIGATION SHOWED THAT THE VALVE WAS EASY TO ADJUST IN ALL PRESSURE LEVELS. TO MEASURE THE BRAKE RELEASE FORCE, WE CHECKED THE VALVE WITH A BRAKE FORCE METER. HOUSING MUST BE EXERCISED TO RELEASE THE ROTOR TO THE VALVE, THROUGH THE MAGNET INTEGRATED IN THE DEVICE. THE BRAKE FUNCTION WAS POSITIVE. THE MEASURED VALUES OF THE BRAKING FORCE ARE WITHIN THE PERMISSIBLE TOLERANCE. BASED ON INVESTIGATION RESULTS, WE COULD NOT CONFIRM THE REPORTED EVENT. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT IS REPORTED THAT VALVE ADJUSTMENT IS NOT ADJUSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118033 PROGAV SHUNTSYSTEM PROGAV JXG CHRISTOPH MIETHKE GMBH & CO. KG FV427T 20029372

    Patients

    Seq Age Sex Outcome Treatment
    1 Other