BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIASYS

    MDR report key: 1215764 · Received October 27, 2008

    Report

    Report Number
    2021710-2008-00091
    Event Type
    Death
    Date Received
    October 27, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 22, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARDINAL HEALTH POST MARKET QUALITY ASSURANCE DEPT SENT A FAX TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. AS OF THE DATE OF THIS REPORT, THE USER FACILITY HAS NOT RESPONDED TO THE FAX. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE AND A CARDINAL HEALTH RESPIRATORY SALES REPRESENTATIVE. THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CARDINAL HEALTH FIELD SERVICE REP. THE CARDINAL HEALTH FIELD SERVICE REP EVALUATED THE DEVICE AND WAS NOT ABLE TO REPRODUCE THE REPORTED FAILURE, THUS WAS NOT ABLE TO IDENTIFY A ROOT CAUSE IN THIS ALLEGED EVENT. DURING THE EVALUATION, THE FIELD SERVICE REP IDENTIFIED THAT THE OXYGEN SENSOR NEEDED TO BE REPLACED. THE DEVICE WAS NOT DELIVERING ACCURATE OXYGEN CONCENTRATIONS WHEN SET TO DELIVER 80% OXYGEN. PER CARDINAL HEALTH FIELD SERVICE REP, THE PROPER OXYGEN CONCENTRATION WAS BEING DELIVERED TO THE PATIENT. THE CARDINAL HEALTH FIELD SERVICE REP REPLACED THE OXYGEN SENSOR AND RAN THE UNIT THROUGH A COMPLETE CHECKOUT TO ENSURE IT MEETS ALL FACTORY SPECS. UPON COMPLETION, THE UNIT WAS RETURNED TO THE CUSTOMER TO BE PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. [IN 2008 6:00:14 AM], "[NAME REMOVED] CALLED IN THIS MORNING ASKING HOW CAN THE AVEA PRINT THE SCREEN. THE CUSTOMER WAS TRYING TO PRINT THE SCREEN AND USING THE USB PORT. I EXPLAINED TO HIM THE USB PORT IS INACTIVE AND THEY NEED TO USE A PARALLEL PRINTER PORT TO MAKE THIS WORK. [NAME REMOVED] WAS UPSET THAT WE HAVE A PORT AND IT DOES NOT WORK, I EXPLAINED IT MAY BE USED AT SOME TIME IN THE FUTURE. ANYWAY, [NAME REMOVED] PROCEEDS TO TELL ME THE VENT WAS INVOLVED IN AN INCIDENT INVOLVING A PT AND THE PT EXPIRED. THE BIOMED WAS TRYING TO PRINT THE EVENT LOG AND THE TRENDS SCREEN WITH NO SUCCESS BECAUSE HE WAS USING THE USB PORT. [NAME REMOVED] STATED HE WOULD HAVE THE CUSTOMER CALL IN AND HE THEN ENDED THE CALL." [7:39:15 AM], "CUSTOMER CALLED AND REPORTED THAT THEY NEEDED TO PRINT THE SCREEN OF THE AVEA AND WERE TRYING TO DO SO WITH THE USB PORT ON THE VENT. I EXPLAINED THEY NEEDED TO USE THE PARALLEL PORT. AT THIS TIME, THE BIOMED REPORTED THE INCIDENT: APPARENTLY THE NURSE WAS BATHING THE PT AND SHE REPORTED THE VENT STOPPED WORKING SO THEY BAGGED THE PT AND THE PT EXPIRED. THE RESP THERAPIST ON DUTY CHECKED THE VENT WHERE IT WAS AND THE VENT CIRCUIT HAD A LARGE LEAK. THE VENT TREND SCREEN APPARENTLY SHOWED THAT THERE WAS A 3% LEAK THAT HAD CHANGED TO AN 85% LEAK. ONCE THE LEAK WAS CORRECTED, A TEST LUNG WAS INSTALLED; THE VENT WORKED PERFECTLY. THE BIOMED [NAME REMOVED] WAS TESTING IT WITH NO OTHER ISSUES AND BOTH RESPIRATORY THERAPY AND BIOMED FEEL IT WAS USER ERROR AT THE TIME OF THE INCIDENT. BIOMED IS ATTEMPTING TO PRINT THE EVENTS AND TRENDING SCREENS FOR THE TIME OF THE INCIDENT TO SHOW IT WAS NOT THE MACHINE. THEY DID NOT REQUEST FIELD SERVICE OR ANY OUTSIDE HELP." [FIVE DAYS LATER, 12:31:16PM], "CUSTOMER CLAIMS THIS UNIT WAS NOT CYCLING, UNIT WAS ON A PATIENT AT THE TIME OF THE INCIDENT, PATIENT DIED. BIOMED MENTIONED THAT THE DOCTORS ARE 99% SURE THE DEATH WAS NOT CAUSED BY THE VENTILATOR, THE PATIENT WAS VERY SICK AND EXPECTED TO DIE. VENT SETTINGS: MODE = VOLUME A/C. RATE = 20 BPM. TIDAL VOLUME = 500 ML'S. PEAK FLOW = 65 LPM. PEEP = 5 CM. FLOW TRIGGER = 1.0. FIO2% = 45%. CUSTOMER FAXED INCIDENT REPORT TO US, HOSPITAL WANTS FIELD SERVICE TO COME IN AND CHECK THIS UNIT, AND ENSURE EVERY THING IS OK, SO THEY CAN PUT IT BACK IN SERVICE. NO SOFTWARE PROVIDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS VOLUME VENTILATOR CBK CARDINAL HEALTH 207, INC AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death