BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE

    MDR report key: 532310 · Received March 4, 2004

    Report

    Report Number
    2184009-2004-00024
    Event Type
    Malfunction
    Date Received
    March 4, 2004
    Date of Event
    February 2, 2004
    Report Date
    February 3, 2004
    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

    INFO RECEIVED INDICATES THAT TOWARD THE END OF THE CASE POOR PRODUCT PERFORMANCE WAS NOTED WHEN THE UNIT ALLOWED AIR TO BACK-UP WITHIN THE CIRCUIT. THE PRODUCT PROBLEM WAS CORRECTED DURING THE CASE WITH NO EFFECT TO THE PT.

    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 0311002177

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention