BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTRAC SENSOR

    MDR report key: 1395408 · Received May 29, 2009

    Report

    Report Number
    2015691-2009-10704
    Event Type
    Malfunction
    Date Received
    May 29, 2009
    Date of Event
    April 2, 2009
    Report Date
    April 2, 2009
    Manufacturer
    EDWARDS LIFESCIENCES. DR
    Product Code
    DRS
    PMA / PMN Number
    K043065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORT WAS CONFIRMED. REC'D (1) SINGLE DPT WITHOUT ANY ATTACHED COMPONENT. LEAKAGE WAS FOUND AT ZERO-STOPCOCK AREA. THE LUER OF ROTATE CONNECTOR WAS BROKEN.

    Description of Event or Problem · 1

    C-CC-LK - LEAKAGE FLO-0904-003; IT WAS REPORTED THAT LEAKAGE WAS OBSERVED FROM THE ZERO THREE WAY STOP COCK AT PRIMING. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOTRAC SENSOR DISPOSABLE PRESSURE TRANSDUCER DRS EDWARDS LIFESCIENCES. DR MHD6S 58619893

    Patients

    Seq Age Sex Outcome Treatment
    1