BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGAVSA SHUNTSYSTEM

    MDR report key: 7570846 · Received June 5, 2018

    Report

    Report Number
    3004721439-2018-00100
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    May 8, 2018
    Report Date
    August 21, 2019
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K141687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 SHUNTSYSTME WAS RECEIVED IN THE PROGAV2.0 PACKAGING AND WAS INVESTIGATED BY THE FIRM. A VISUAL INSPECTION WAS PERFORMED AND NO ABNORMALITIES WERE FOUND. THE VALVE WAS SET TO 40 CM2O AT THE TIME OF DELIVERY SO THERE WAS NO ADJUSTMENT REQUIRED ON THE PRODUCT. AN ADJUSTMENT TEST WAS CARRIED OUT WITH THE STANDARD PROSA CHECK MATE AND MEASUREMENT TOOL. THE VALVE WAS ADJUSTED FROM 0 UPT TO 40 CM2O AND DOWN AGAIN. THE ADJUSTMENTS FUNCTIONED PROPERLY. THE BRAKE WAS ALSO TESTED ON THE VALVE TO ENSURE IT COULD NOT BE ADJUSTED ON ITS OWN. THE SYSTEM OPERATED AS INTENDED. THERE WAS NO FAILURE DETECTED WITH THIS VALVE. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: USA. IT WAS REPORTED THE THE PO VALVE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411716 PROGAVSA SHUNTSYSTEM PRO GAV 2.0 JXG CHRISTOPH MIETHKE GMBH & CO. KG FX991T 20035976

    Patients

    Seq Age Sex Outcome Treatment
    1 Other