BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/VAMP SYSTEM

    MDR report key: 1013219 · Received March 12, 2008

    Report

    Report Number
    6000002-2008-06150
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 24, 2008
    Report Date
    February 26, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RECEIVED FOR EVAL AT THIS TIME.

    Description of Event or Problem · 1

    REPORTED LEAKING FROM VAMP TAPE WHILE IN USE. SYSTEM WAS CHANGED OUT. NO PT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/VAMP SYSTEM PRESSURE TRANSDUCER AND BLOOD SAMPLING KIT DRS EDWARDS LIFESCIENCES PXVP0651 58407593

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK