BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/VAMP KIT COMBO

    MDR report key: 1122170 · Received August 14, 2008

    Report

    Report Number
    6000002-2008-08420
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    February 21, 2008
    Report Date
    July 18, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    BREAKING OF THE BLUE TAB DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/VAMP KIT COMBO DISPOSABLE PRESSURE MONITOR/BLOOD SAMPLING KIT DRS EDWARDS LIFESCIENCES T100209A 58476955

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN