BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1003939 · Received January 29, 2008

    Report

    Report Number
    1003939
    Event Type
    Malfunction
    Date Received
    January 29, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 29, 2008
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    PRESSURE MONITORING KIT WITH TRANSDUCER DID NOT PROPERLY TRANSDUCE CVP WAVEFORM AND HAD TO BE REPLACED WITH SECOND TRANSDUCER. ONCE REPLACED APPROPRIATE WAVEFORMS WERE OBTAINED.====================== MANUFACTURER RESPONSE FOR PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER, EDWARDS======================WILL SEND MANUFACTURER A COPY OF THIS MEDWATCH AND OFFER TO RETURN DEVICE UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * KIT, PRESSURE MONITORING, INVASIVE DRS EDWARDS LIFESCIENCES LLC PX260 58422207

    Patients

    Seq Age Sex Outcome Treatment
    1 *