BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE

    MDR report key: 587324 · Received March 25, 2005

    Report

    Report Number
    2184009-2005-00024
    Event Type
    Malfunction
    Date Received
    March 25, 2005
    Date of Event
    March 7, 2005
    Report Date
    March 7, 2005
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    MNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNIT LEAKED DURING THE PROCEDURE AND WAS CHANGED OUT. THE PRODUCT WAS REPLACED DURING BYPASS WITH NO PATIENT COMPLICATION REPORTED OTHER THAN A MINIMAL BLOOD LOSS OF APPROXIMATELY 5 CC'S NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE VACUUM RELIEF VALVE MNJ MEDTRONIC PERFUSION SYSTEMS VRV-100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention