BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RLV-2100 VACUUM RELIEF VALVE

    MDR report key: 7064305 · Received November 28, 2017

    Report

    Report Number
    1649914-2017-00099
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Report Date
    February 16, 2018
    Manufacturer
    QUEST MEDICAL, INC
    Product Code
    DWD
    PMA / PMN Number
    K864503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. A FOLLOW MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED THROUGH SIMULATED USE TESTING AND IT FUNCTIONED AS INTENDED. NO LEAK WAS OBSERVED. THE DEVICE IS INTENDED TO RELIEVE PRESSURE AT NEGATIVE PRESSURE OF -200MMHG AND POSITIVE PRESSURE BUILD UP OF <1300MMHG (AVG). A DHR REVIEW WAS CONDUCTED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RETURNED FOR INVESTIGATION. A DHR REVIEW WAS CONDUCTED AND NO ANOMALIES WERE IDENTIFIED . THE MANUFACTURING PROCESS FOR THIS DEVICE INVOLVES A 100% INSPECTION FOR LEAK. THE ROOT CAUSE OF THE ISSUE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A LEAKAGE ON THE VALVE THAT OCCURS WHEN PRESSURE RISES ABOVE 100MMHG. THE LEAKAGE WAS IDENTIFIED DURING PRIMING. THERE WERE NO REPORTED PATIENT COMPLICATIONS RESULTING FROM THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841882 RLV-2100 VACUUM RELIEF VALVE CARDIOPULMONARY SUCTION CONTROL DEVICE DWD QUEST MEDICAL, INC 4103202 050997

    Patients

    Seq Age Sex Outcome Treatment
    1