BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFT ARTERIAL PRESSURE MONITORING CATHETER

    MDR report key: 923683 · Received October 2, 2007

    Report

    Report Number
    6000002-2007-05202
    Event Type
    Malfunction
    Date Received
    October 2, 2007
    Date of Event
    September 12, 2007
    Report Date
    September 12, 2007
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    NO LETTER REQUIRED REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEFT ARTERIAL PRESSURE MONITORING CATHETER PRESSURE MONITOR CATHETER DRS EDWARDS LIFESCIENCES RESEARCH MEDICAL LAP17 58309587

    Patients

    Seq Age Sex Outcome Treatment
    1 YR