BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE DPT/VAMP

    MDR report key: 926005 · Received October 8, 2007

    Report

    Report Number
    6000002-2007-52850
    Event Type
    Malfunction
    Date Received
    October 8, 2007
    Date of Event
    May 31, 2007
    Report Date
    May 31, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    AFTER THIRTY MINUTES OF USE ARTAFACTS, SPIKES AND DRAFTING OF SIGNAL UPWARDS. THEN NOT ABLE TO ZERO. AFTER REPLACING PDT, PROBLEM DISAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE DPT/VAMP DISPOSABLE PRESSURE TRANSDUCER VENOUS ARTERIAL BLOOD MANAGE DRS EDWARDS LIFESCIENCES T001671A 58281041

    Patients

    Seq Age Sex Outcome Treatment
    1 YR