BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUUM RELIEF VALVE

    MDR report key: 369030 · Received December 26, 2001

    Report

    Report Number
    2184009-2001-00090
    Event Type
    Malfunction
    Date Received
    December 26, 2001
    Date of Event
    December 3, 2001
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    MNJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THEY NOTED OBSTRUCTED FLOW DURING CARDIAC BYPASS. THE VALVE WAS CHANGED OUT WITH NO AFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58491 VACUUM RELIEF VALVE VACUUM RELIEF VALVE MNJ MEDTRONIC PERFUSION SYSTEMS VRV100 0105005008

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other