BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCERW/VAMP COMBO

    MDR report key: 1112513 · Received August 8, 2008

    Report

    Report Number
    6000002-2008-08304
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 16, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAKAGE OF TUBING AT THE COLORED MARKINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCERW/VAMP COMBO DISPOSABLE PRESSURE MONITOR AND BLOOD SAMPLING KIT DRS EDWARDS LIFESCIENCES T001752A 58493975

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK