BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC VRV-100

    MDR report key: 274084 · Received April 12, 2000

    Report

    Report Number
    2022036-2000-00012
    Event Type
    Malfunction
    Date Received
    April 12, 2000
    Date of Event
    March 13, 2000
    Manufacturer
    MEDTRONIC CARDIOPULMONARY- ANAHEIM
    Product Code
    MNJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT AT THE END OF BYPASS, THE VACUUM RELIEF VALVE FAILED. THE LINE WAS REPLACED WITH NO EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC VRV-100 VACUUM RELIEF VALVE MNJ MEDTRONIC CARDIOPULMONARY- ANAHEIM 1140333-1 9904002850

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other