BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE

    MDR report key: 696659 · Received April 3, 2006

    Report

    Report Number
    2184009-2006-00028
    Event Type
    Malfunction
    Date Received
    April 3, 2006
    Date of Event
    March 10, 2006
    Report Date
    March 10, 2006
    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

    THE VALVE LEAKED DURING BYPASS IN A VENT APPLICATION. THE UNIT WAS REPLACED DURING THE CASE WITH NO PATIENT COMPLICATION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 3265856

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention