BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCO CATHETER INTERFACE CABLE

    MDR report key: 1081041 · Received July 18, 2008

    Report

    Report Number
    6000002-2008-08120
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    PMA / PMN Number
    K043103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: CABLE PASSED ALL THE TESTS PER SOP 4001. NO DEFECT FOUND.

    Description of Event or Problem · 1

    REPORTEDLY, CCO/CO NOT WORKING, BLOOD LEAKED THROUGH CATHETER INTO AND THROUGH CABLE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CCO CATHETER INTERFACE CABLE INTERFACE CABLE DYG EDWARDS LIFESCIENCES 70CC2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK