BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASCAL PHOTOCOAGULATOR

    MDR report key: 1030925 · Received April 17, 2008

    Report

    Report Number
    3005675890-2008-00001
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K043486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2008, THE SAME FIELD SERVICE ENGINEER WHO HAD INITIALLY PERFORMED THE SOFTWARE UPGRADE THE DAY BEFORE, WENT BACK ON-SITE TO EVALUATE THE PASCAL SYSTEM AND WAS ABLE TO REPLICATE THE REPORTED PROBLEM. THE NORMAL USER MODE FUNCTIONED CORRECTLY, BUT IF A "FAVORITE" WAS RECALLED, AN ABNORMAL SITUATION WAS CREATED WHEREIN THE LASER COULD BE FIRED WITHIN "STANDBY" MODE. AFTER INVESTIGATION, THE ROOT CAUSE OF THIS PROBLEM WAS DETERMINED TO BE IMPROPER INSTALLATION OF SOFTWARE UPGRADE DUE TO THE FIELD SERVICE ENGINEER NOT PROPERLY FOLLOWING THE SERVICE BULLETIN INSTRUCTIONS (SB-00011, DATED MAY 31, 2007). THE FIELD SERVICE ENGINEER THEN DELETED THE ORIGINAL "FAVORITES" FILE AND PROPERLY REPROGRAMMED THE PHYSICIAN'S FAVORITE FILE AS INSTRUCTED IN THE SERVICE BULLETIN (SB-00011, DATE MAY 31, 2007). THE FIELD SERVICE ENGINEER INVOLVED WAS RECENTLY TRAINED AND IT WAS CONFIRMED THAT THIS WAS HIS ONLY SOFTWARE UPGRADE. THIS FIELD SERVICE ENGINEER HAD BEEN RE-TRAINED ON THE PROPER PROCEDURE FOR A SOFTWARE UPGRADE INSTALLATION PRIOR TO REPROGRAMMING. THIS WAS DETERMINED TO BE AN ISOLATED EVENT.

    Description of Event or Problem · 1

    IN 2008, AN EVENT WAS REPORTED TO OPTIMEDICA CORPORATION INVOLVING THE PASCAL PHOTOCOAGULATOR FIRING WHILE THE PHYSICIAN WAS EVALUATING THE PASCAL SYSTEM IN THE "STANDBY" MODE. THIS ISSUE WAS CAUSED BY AN IMPROPER SOFTWARE INSTALLATION BY AN OPTIMEDICA FIELD SERVICE ENGINEER DURING A SOFTWARE UPGRADE. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT. DETAILS OF THE EVENT ARE PROVIDED BELOW: THE PHYSICIAN CONTACTED THE TECHNICAL SERVICE DEPARTMENT AT OPTIMEDICA ON THIS DAY AND REPORTED THAT ONE OF HIS SAVED "FAVORITES" (PRE-DEFINED SETTINGS THAT ARE PROGRAMMED IN THE PASCAL SYSTEM) COULD NOT BE RECALLED. HE EVALUATED THE PASCAL SYSTEM AND ALSO REPORTED THAT HE WAS ABLE TO FIRE THE LASER EVEN THOUGH THE PASCAL SYSTEM DISPLAYED A SYSTEM STATUS OF "STANDBY". THERE WAS NO PATIENT INVOLVEMENT. EARLIER THAT DAY, AN OPTIMEDICA FIELD SERVICE ENGINEER HAD PERFORMED A SOFTWARE UPGRADE ON THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASCAL PHOTOCOAGULATOR GEX OPTIMEDICA CORPORATION PASCAL-US NA

    Patients

    Seq Age Sex Outcome Treatment
    1