BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1953084 · Received January 7, 2011

    Report

    Report Number
    2090040-2011-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    February 1, 2011
    Manufacturer
    ASCENT
    Product Code
    NLI
    PMA / PMN Number
    K092425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS EVALUATED BY ASCENT. THE DEVICE PASSED ALL VISUAL INSPECTION AND FUNCTION TESTING. TO DETERMINE THE LAST TIME THE DEVICE WAS CONNECTED VIA THE HYPERTRONIC CONNECTOR, THE MEMORY DATA WAS EXTRACTED. THE MEMORY DATA SPECIFIED THAT THE LAST TIME THE DEVICE WAS CONNECTED VIA THE HYPERTRONIC CONNECTOR WAS (B)(6) 2010 AT 2:02 AM EASTERN TIME. THE DEVICE HISTORY REPORT FOR THE DEVICE WAS ALSO REVIEWED AND IT WAS DETERMINED THAT THE DEVICE WAS SUCCESSFULLY REPROGRAMMED ON (B)(6) 2010. DURING THE REPROGRAMMING PROCESS THE DEVICE'S PREVIOUS TIME STAMP IS EXPUNGED TO ALLOW FOR THE NEW TIME STAMP AND MEMORY INFORMATION TO BE RECORDED. AFTER THE DEVICE IS CONNECTED VIA THE HYPERTRONIC CONNECTOR, THERE IS A 24-HOUR WINDOW OF OPERATION IN WHICH THE DEVICE MUST BE USED BEFORE THE CONSOLE INDICATES THAT THE DEVICE HAS EXPIRED. DURING THE INVESTIGATION THE DEVICE WAS ALSO REPROGRAMMED TO ENSURE THAT THE DEVICE COULD BE ENCRYPTED AND READ. IT PASSED ALL MEMORY REPROGRAMMING TESTING. SINCE THE DEVICE WAS CORRECTLY PROGRAMMED WHEN LEAVING ASCENT AND COULD BE SUCCESSFULLY ENCRYPTED AND READ, THE COMPLAINT IS NOT CONFIRMED. THE MOST PROBABLE ROOT CAUSE FOR THE "EXPIRED" ERROR MESSAGE IS THAT AFTER THE DEVICE LEFT ASCENT, BUT PRIOR TO THE TIME OF THE OPERATION, IT WAS CONNECTED VIA THE HYPERTRONIC CONNECTOR WHICH TIME STAMPED THE DEVICE. IF THE TIME BETWEEN WHEN THE DEVICE WAS CONNECTED AND THE START OF THE OPERATION SURPASSED 24 HOURS, THE CONSOLE WOULD INDICATE THAT THE DEVICE HAD EXPIRED. THIS IS THE FIRST COMPLAINT THAT ASCENT HAS RECEIVED FOR THE DEVICE BEING EXPIRED.

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT THE DEVICE INVESTIGATION HAS NOT BEEN COMPLETED. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "CARTO III SYSTEM DISPLAYED A MESSAGE THAT THE ASCENT" ULTRASOUND CATHETER WAS EXPIRED. THE PROCEDURE TIME WAS EXTENDED 1.5 HOURS TO TROUBLE-SHOOT AND REPLACE THE DEVICE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLI NLI ASCENT SNDSTR10

    Patients

    Seq Age Sex Outcome Treatment
    1