BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRU-WAVE DISPOSABLE PRESSURE MONITOR

    MDR report key: 1032442 · Received April 16, 2008

    Report

    Report Number
    6000002-2008-06411
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 11, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAKAGE FROM THE CRACK ON THE FEMALE LUER OF THE DPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRU-WAVE DISPOSABLE PRESSURE MONITOR PRESSURE MONITOR SYSTEM DRS EDWARDS LIFESCIENCES 500488003 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN