BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3222755 · Received July 12, 2013

    Report

    Report Number
    1644487-2013-02084
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    July 18, 2012
    Report Date
    June 19, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2013 PRODUCT ANALYSIS WAS COMPLETED ON THE HANDHELD AND FLASHCARD. AN ANALYSIS WAS PERFORMED ON THE RETURNED HANDHELD AND 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. AN ANALYSIS WAS PERFORMED ON THE RETURNED FLASHCARD AND NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013 INFORMATION WAS RECEIVED FROM THE REPORTER THAT THE PHYSICIAN¿S HANDHELD COMPUTER WAS NOT HOLDING A CHARGE. IT WAS STATED THAT THE PHYSICIAN TRIED SWITCHING ELECTRICAL OUTLETS BUT THAT THE COMPUTER WOULD ONLY HOLD A CHARGE FOR ONE INTERROGATION AFTER BEING UNPLUGGED, AND THEN THE BATTERY WOULD DIE. THE COMPUTER WAS STORED IN A REGULAR OFFICE ENVIRONMENT. IT WAS DETERMINED THAT THE CHARGE HOLDING ISSUE WITH THE COMPUTER FIRST AROSE ON (B)(6) 2012, WHEN THE PHYSICIAN REPORTED THAT HE WAS HAVING DIFFICULTY GETTING THE COMPUTER TO HOLD A CHARGE. IT WAS SUGGESTED THAT PHYSICIAN USE A DIFFERENT ELECTRICAL OUTLET AT THAT TIME AND THE PHYSICIAN PROVIDED NO MORE INFORMATION ON THE ISSUE. THE COMPUTER HAS NOW BEEN REPLACED WITH A NEW COMPUTER AND THE ORIGINAL HAS BEEN RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS. ATTEMPTS FOR ADDITIONAL INFORMATION WILL REMAIN IN CONTINUATION PENDING PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    THE HANDHELD COMPUTER WAS RETURNED FOR THE ALLEGATION THAT THERE WAS A BATTERY FAILURE AND THAT AS A RESULT THE BATTERY WOULD NOT HOLD A CHARGE. THE HANDHELD COMPUTER WAS RECEIVED WITH A VERSION 8.1 FLASHCARD AND WITH THE MAIN BATTERY DEPLETED. THE HANDHELD COMPUTER WAS ALSO RECEIVED WITH AN AC ADAPTER. A VISUAL INSPECTION IDENTIFIED NO ANOMALIES. THE BACK-UP BATTERY VOLTAGE WITH NO LOAD MEASURED 464 MV (NOMINAL 3V), INDICATING THAT THE BACK-UP BATTERY HAD BEEN DEPLETED. THE HANDHELD DEVICE WAS POWERED USING THE RETURNED AC POWER SUPPLY ADAPTER WITH NO OBSERVED ANOMALIES. THE INITIAL SETUP PROCESS WAS PERFORMED WITH NO OBSERVED ANOMALIES. THE BACK-UP BATTERY INDICATOR READ 0%, WHICH 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%., WHICH IS EVIDENCE THAT THE HANDHELD BATTERY INDICATOR IS OPERATING PROPERLY. INTERROGATION AND DIAGNOSTIC TESTS WERE PERFORMED SUCCESSFULLY WITH NO OBSERVED ANOMALIES USING THE V8.1 SOFTWARE AND A 103 GENERATOR. THE HANDHELD¿S MAIN BATTERY WAS FULLY RECHARGED SUCCESSFULLY USING A POWER SUPPLY ADAPTER. INTERROGATION AND DIAGNOSTIC TESTS WERE PERFORMED SUCCESSFULLY WITH NO OBSERVED ANOMALIES USING A 102 GENERATOR. THE HANDHELD COMPUTER WAS POWER-ON CONTINUOUSLY USING ONLY THE MAIN BATTERY FOR MORE THAN AN HOUR. FOR FIVE SUCCESSFUL TIMES THE FOLLOWING OCCURRED: THE GENERATOR WAS INTERROGATED, THEN THE OUTPUT AND MAGNET CURRENTS INCREASED FROM 0MA TO 0.5MA, THEN INTERROGATED TO VERIFY THE NEW SETTINGS, THEN A GENERATOR DIAGNOSTIC TEST WAS PERFORMED DURING WHICH THE GENERATOR VALUES WERE CHANGED BACK TO OUTPUT CURRENTS OF 0MA, AND THEN THE BATTERY WAS INTERROGATED TO VERIFY NEW SETTINGS. AT THE CONCLUSION OF TESTING, THE MAIN BATTERY HAD A REMAINING CHARGE OF 71%. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE ANALYSIS PERFORMED ON THE RETURNED HANDHELD COMPUTER DID NOT VERIFY THE ALLEGATION OF THE BATTERY FAILURE. NO ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. PRODUCT ANALYSIS OF THE FLASHCARD IDENTIFIED NO ANOMALIES VIA EXTERNAL VISUAL INSPECTION. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322043 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1075840

    Patients

    Seq Age Sex Outcome Treatment
    1