BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE

    MDR report key: 695341 · Received March 29, 2006

    Report

    Report Number
    2184009-2006-00024
    Event Type
    Malfunction
    Date Received
    March 29, 2006
    Date of Event
    February 27, 2006
    Report Date
    February 27, 2006
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    MNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE VALVE LEAKED IN THE VENT LINE DURING BYPASS. THE VALVE WAS REPLACED WITH A CONNECTOR AND THE CASE WAS COMPLETED WITH NO PT COMPLICATION REPORTED.

    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 0507005748

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention