BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH W/VAMP PLUS SYSTEM

    MDR report key: 1082352 · Received July 24, 2008

    Report

    Report Number
    6000002-2008-08176
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    PMA / PMN Number
    CLASS I EXEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    LEAKAGE WAS OBSERVED FROM THE CONNECTION BETWEEN VAMP PLUS AND THE ONE WAY STOP COCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH W/VAMP PLUS SYSTEM DISPOSABLE PRESSURE MONITOR AND BLOOD SAMPLING KIT DRS EDWARDS LIFESCIENCES 600380081 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK