BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/VAMP KIT

    MDR report key: 1034052 · Received April 24, 2008

    Report

    Report Number
    6000002-2008-06555
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 2, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTS WERE NOT CONNECTED WHEN OPENED. NO PT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/VAMP KIT DISPOSABLE PRESSURE MONITOR AND BLOOD SAMPLING KIT DRS EDWARDS LIFESCIENCES PXVP0765 58480622

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK