BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANCE PATIENT CABLE

    MDR report key: 4889223 · Received July 2, 2015

    Report

    Report Number
    2015691-2015-01604
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K000664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CABLE WAS MANUFACTURED 09-JUL-2010 AND REVIEW OF THE DEVICE HISTORY RECORD SUPPORTS THAT THERE WERE NO NON-CONFORMANCES FOR ANY REASON. AS OF JANUARY 2009, EXTENSIVE TESTING TO DETERMINE THE USEFUL LIFE OF THE CABLE WAS CONDUCTED AND DETERMINED TO BE 3 YEARS. THIS INFORMATION WAS PROVIDED TO EDWARDS CUSTOMERS VIA A PRODUCT NOTIFICATION WHICH INCLUDED RECOMMENDATIONS FOR CABLE REPLACEMENT AND/OR RETURN TO EDWARDS FOR EVALUATION FOLLOWING THE ESTABLISHED TIME-PERIOD. NEW PRODUCT LABELING NOW INCLUDES INFORMATION REGARDING THE USEFUL LIFE OF THE PRODUCT. THE REPORTED HAS SIGNIFICANTLY EXCEEDED ITS EXPECTED LIFE. EXAMINATION OF THE RETURNED CABLE WAS UNABLE TO FIND ANY FAILURE OF THE DEVICE TO PERFORM AS EXPECTED. THE CUSTOMER¿S COMPLAINT WAS UNABLE TO BE CONFIRMED. A CABLE SELFTEST WAS EXECUTED USING THE VIG 2 MONITOR, CIRRIS FUNCTIONAL TESTING AND SR720 LCR TESTING WERE ALL SATISFACTORY AND SUPPORT THAT THERE WAS NO FAILURE INVOLVING THE CABLE. NO PHYSICAL DAMAGE WAS OBSERVED AND CCO WAS RUN FOR OVER 10 MINUTES WITH NO OBSERVED ISSUES. IT IS UNKNOWN WHETHER PROCEDURAL PROCESSES OR A SPECIFIC CIRCUMSTANCE PLAYED A ROLE IN THE CUSTOMER¿S EXPERIENCE, AS THE FAULT COULD NOT BE REPLICATED AND THERE WAS NO EVIDENCE OF ANY OTHER FAILURE WHICH COULD ACCOUNT FOR THE CUSTOMER¿S EXPERIENCE. THE ASSOCIATED MONITOR WAS ALSO EVALUATED AND ABSOLVED AS CONTRIBUTING TO THE CUSTOMER'S EXPERIENCE. THE CABLE WILL BE RETURNED TO THE CUSTOMER AND NO FURTHER ACTIONS WILL BE PURSUED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE MANUFACTURING RECORDS WERE REVIEWED AND THIS DEVICE PASSED ALL MANUFACTURING INSPECTIONS WITH NO NON-CONFORMANCES IDENTIFIED. THE DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN; THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. ANY ADDITIONAL INFORMATION LEARNED WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NO FURTHER ACTIONS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAYED CONTINUOUS CARDIAC OUTPUT (CCO) VALUE WAS ABNORMAL. THERE WAS NO INAPPROPRIATE TREATMENT PERFORMED DUE TO THIS ABNORMAL VALUE. THERE WAS NO PATIENT INJURY REPORTED. NO OTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429846 VIGILANCE PATIENT CABLE COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES 70CC2 S10709

    Patients

    Seq Age Sex Outcome Treatment
    1