BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/ VAMP COMBO

    MDR report key: 1082837 · Received July 24, 2008

    Report

    Report Number
    6000002-2008-08194
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 26, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    MESSAGE 'DISCONNECTED ARTERY' RECEIVED LETTER REQUIRED REPLACEMENT STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/ VAMP COMBO DISPOSABLE PRESSURE MONITOR AND BLOOD SAMPLING KIT DRS EDWARDS LIFESCIENCES T001631A 58436531

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK