BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APCO9 CABLE

    MDR report key: 6099562 · Received November 14, 2016

    Report

    Report Number
    2015691-2016-03356
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 9, 2016
    Report Date
    October 27, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K131588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, NEW INFORMATION WAS RECEIVED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE SERIAL/LOT NUMBER OF THE MONITOR WAS NOT PROVIDED THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED. WITHOUT RETURN OF THE DEVICE, THE CUSTOMER¿S ALLEGATION IS UNABLE TO BE CONFIRMED OR NEGATED. WITH ANY HEMODYNAMIC MONITORING, PRESSURE READINGS CAN CHANGE QUICKLY AND DRAMATICALLY. PRESSURE READINGS SHOULD CORRELATE WITH THE PATIENT'S CLINICAL MANIFESTATIONS. IT IS UNKNOWN WHETHER USER OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE EVALUATED; HOWEVER, AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO COMMUNICATE THE RESULTS OF THE COMPLAINT INVESTIGATION RESULTS. THE VIGILEO MONITOR WAS ALSO SUBMITTED AND THE MDR NUMBER IS 2015691-2016-03253.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF A VIGILEO MONITOR AND APCO9 CABLE ON A SEVERELY BURNED PATIENT THE SVV VALUES DID NOT FLUCTUATE AS ANTICIPATED BY THE CLINICIAN GIVEN THE PATIENTS CLINICAL PRESENTATION. THERE WERE NO FAULT/ALERT MESSAGES OBSERVED, THE CONNECTIONS WERE CHECKED AND THE MONITOR WAS RESTARTED BUT THE PROBLEM WAS NOT RESOLVED. THE VIGILEO MONITOR AND APCO9 CABLE WERE EXCHANGED FOR ANOTHER SET AND THE PROBLEM WAS SOLVED. THE PATIENT WAS NOT TREATED ACCORDING TO THE INACCURATE VALUES. NO PATIENT COMPROMISE WAS REPORTED. NO PATIENT DEMOGRAPHICS WERE AVAILABLE. NO OTHER SYSTEM RELATED DEVICES WERE REPORTED AS SUSPECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752183 APCO9 CABLE COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES APCO9 5342672

    Patients

    Seq Age Sex Outcome Treatment
    1 VIGILEO MONITOR