BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2895481 · Received January 3, 2013

    Report

    Report Number
    1644487-2013-00033
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 1, 2012
    Report Date
    December 6, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(4) 2012, THE PHYSICIAN REPORTED THAT HIS HANDHELD CONTINUES TO FREEZE AT THE "INTERROGATION SUCCESSFUL" SCREEN, BUT EVENTUALLY UNFREEZES AFTER A FEW MINUTES. NO TROUBLESHOOTING WAS REQUIRED TO RESOLVE THE ISSUE; HOWEVER, THE ISSUE STARTED ABOUT A MONTH PRIOR TO THE REPORT. A NEW HANDHELD WAS SHIPPED TO THE PHYSICIAN AND THE OLD ONE IS PENDING RETURN FOR PRODUCT ANALYSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE HANDHELD AND FLASCHARD WERE RETURNED ON (B)(4)2013. PRODUCT ANALYSIS OF THE FLASCHARD DID NOT VERIFY THE FROZEN SCREEN EVENT. DURING THE ANALYSIS, NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO SPECIFICATIONS. NO ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING ANALYSIS, THE BACK-UP BATTERY WAS REMOVED. THE BACK-UP BATTERY VOLTAGE WITH NO LOAD MEASURED 410MV (NOMINAL 3V). THIS IS AN INDICATION THAT THE BACK-UP BATTERY HAS BEEN DEPLETED. THE BACK-UP BATTERY INDICATOR READ 0%. THIS IS EXPECTED BECAUSE THE BACK-UP BATTERY WILL DISCHARGE IF THE UNIT IS NOT SUPPORTED BY AN EXTERNAL POWER SOURCE OR BY MAIN BATTERY POWER. A KNOWN GOOD BACK-UP BATTERY WAS SUBSTITUTED INTO THE HANDHELD AND THE BATTERY INDICATOR READ 100%. THIS IS EVIDENCE THAT THE HANDHELD BATTERY INDICATOR IS OPERATING PROPERLY. THE HANDHELD DEVICE WAS POWERED USING A KNOWN GOOD AC POWER SUPPLY ADAPTER WITH NO OBSERVED ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1075226

    Patients

    Seq Age Sex Outcome Treatment
    1