BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1990008 · Received February 3, 2011

    Report

    Report Number
    1644487-2011-00187
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE PROBLEMS UPGRADING A DELL X50 HANDHELD TO VERSION 8.0 VNS SOFTWARE. AT THE INSTALLATION STEP TO SELECT CF CARD, THE MANUFACTURER REP PRESENT INDICATED THE CF CARD WAS NOT AN OPTION TO SELECT. RESEATING THE FLASHCARD DID NOT RESOLVE THE ISSUE. THE VERSION 7.1 FLASHCARD WAS INSERTED INTO THE HANDHELD, AND A HARD RESET WAS PERFORMED. THE SCREEN WAS FROZEN AT "CLEAR ALL DATA IN MEMORY" SCREEN, AND NONE OF THE BUTTONS WOULD WORK. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE HANDHELD AND SOFTWARE FLASHCARD WERE RETURNED TO MANUFACTURER FOR ANALYSIS. AN ANALYSIS WAS PERFORMED ON THE RETURNED VERSION 8.0 FLASHCARD AND THE REPORTED ALLEGATION WAS VERIFIED. THE CAUSE FOR THE EVENT WAS DETERMINED TO BE ASSOCIATED WITH A DEFECTIVE FLASHCARD. A VISUAL ANALYSIS OF THE PRINTED CIRCUIT BOARD (PCB) IDENTIFIED THAT PIN 27 WAS NOT SOLDERED ONTO THE PCB CAUSING THE HANDHELD TO NOT RECOGNIZE THE FLASHCARD WHEN IT WAS INSERTED. ONCE THE PIN WAS SOLDERED ONTO THE PCB, NO FURTHER ANOMALIES WERE IDENTIFIED. ANALYSIS OF THE HANDHELD REVEALED NO ANOMALIES AND PERFORMED ACCORDING TO SPECIFICATIONS. ANALYSIS OF THE VERSION 7.1 FLASHCARD REVEALED NO ANOMALIES AND PERFORMED ACCORDING TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 840144

    Patients

    Seq Age Sex Outcome Treatment
    1