BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3033510 · Received April 3, 2013

    Report

    Report Number
    1644487-2013-00898
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 5, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD HAS BEEN FREEZING AT THE INTERROGATION SCREEN FOR SEVERAL MONTHS. THE PHYSICIAN REPORTED THAT THE HANDHELD HAS WORKED INTERMITTENTLY AND THAT HE HAS USED HIS OTHER HANDHELD WHEN NEEDED. THE HANDHELD AND FLASHCARD WERE RETURNED TO DEVICE MANUFACTURER FOR ANALYSIS ON (B)(4) 2013. ANALYSIS OF THE HANDHELD REVEALED NO ANOMALIES. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO SPECIFICATIONS. DURING THE ANALYSIS, NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED. DEVICE MANUFACTURER PREVIOUSLY INVESTIGATED SUCH EVENTS AND FOUND THAT THE REPORTED SCREEN FREEZE EVENT OCCURRING AT THE "INTERROGATION SUCCESSFUL" SCREEN IS RESOLVED FOLLOWING A SOFTWARE RESET OF THE HANDHELD OR RESEATING THE FLASHCARD. THIS EVENT ONLY OCCURS ON (B)(4) MODELS OF THE HANDHELD COMPUTERS EXECUTING THE POCKET PC 2002 OPERATING SYSTEM. THIS EVENT MAY TYPICALLY OCCUR AFTER SEVERAL DAYS OF INACTIVITY OR AFTER A DAYLIGHT SAVINGS TIME CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137342 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 1073771

    Patients

    Seq Age Sex Outcome Treatment
    1