BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP COMBO KIT

    MDR report key: 1082663 · Received July 21, 2008

    Report

    Report Number
    6000002-2008-07880
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 26, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    PMA / PMN Number
    K832907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME.

    Description of Event or Problem · 1

    SILICONE OIL WAS OBSERVED INSIDE OF THE TUBING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK