BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VRV II VACUUM RELIEF VALVE

    MDR report key: 7039483 · Received November 16, 2017

    Report

    Report Number
    1649914-2017-00093
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Report Date
    January 18, 2018
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    UDI-DI
    10634624442037
    PMA / PMN Number
    K760894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE OF THE US. A SIMILAR DEVICE IS DISTRIBUTED BY QUEST MEDICAL IN US. THERE WERE NO PATIENT COMPLICATIONS RESULTING FROM THE ALLEGED ISSUE. AT THE TIME OF THIS REPORT, THREE REQUESTS FOR DEVICE RETURN HAVE BEEN SENT TO THE CUSTOMER BUT THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. DHR REVIEW CONDUCTED DID NOT SHOW ANY ANOMALIES DURING PRODUCTION OF THE DEVICE. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND IT FUNCTIONED AS INTENDED. LEAKING WAS OBSERVED FROM THE PRESSURE RELIEF VALVE UNDER THE HOOD AT APPROXIMATELY 9.5 PSI (491 MMHG) WHICH IS WITHIN THE ACCEPTABLE RANGE. THE DEVICE IS INTENDED TO RELIEVE PRESSURE AT NEGATIVE PRESSURE OF -150MMHG AND POSITIVE PRESSURE BUILD UP OF +340MMHG (AVG). A DHR REVIEW WAS CONDUCTED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED AN ISSUE ENCOUNTERED WHILE USING THE CPBP VACUUM RELIEF VALVE. THE REPORT STATES THAT TWO VALVES LEAKED DURING USE IN A HOSPITAL. THE LEAK WAS NOTICED AT THE BASE OF THE DOME OF THE VALVE. THE VALVE WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815750 VRV II VACUUM RELIEF VALVE CPBP VACCUM RELIEF VALVE DWD QUEST MEDICAL, INC. 4004203 050999 10634624442037

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention