BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIASYS

    MDR report key: 2231439 · Received August 26, 2011

    Report

    Report Number
    2021710-2011-00061
    Event Type
    Death
    Date Received
    August 26, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K062093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP AND WRITTEN RESPONSES FROM THE USER FACILITY TO A LETTER SENT BY CAREFUSION SEEKING ADD'L INFO. (B)(4) - THE USER FACILITY DID NOT ALLEGE THAT THE UNIT FAILED IN ANY WAY. THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP. THE CAREFUSION FIELD SERVICE REP CHECKED THE DEVICE'S ERROR LOG AND DID NOT FIND ANY ERRORS/FAILURES RECORDED. THE DEVICE WAS RUN THROUGH A COMPLETE CHECKOUT AND NO PROBLEMS WERE FOUND. THE DEVICE WAS RETURNED TO THE USER FACILITY'S CONTROL READY TO BE PLACED BACK INTO SERVICE. THE USER FACILITY DID NOT ALLEGE THAT THE DEVICE MALFUNCTIONED IN ANY WAY. THEY ONLY REPORTED THAT THE PT EXPIRED WHILE ON THE DEVICE. CAREFUSION ALONG WITH THE USER FACILITY DO NOT BELIEVE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PT'S DEATH IN ANY WAY.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "[NAME REMOVED] IS BIOMED BUT NOT AVEA TRAINED. HE SAID THAT THIS VENT WAS ON A PT WHEN THE PT EXPIRED. HE IS REPORTING THAT THE VENT WORKED CORRECTLY AND AS FAR AS THEY KNOW GAVE ALL CORRECT ALARMS WHEN THE PT EXPIRED. [NAME REMOVED] SAID THE INFO THAT HE COULD RELAY TO ME WAS THAT "THEY SUSPECT HUMAN ERROR AND LACK OF SUPERVISION" TO HAVE BEEN THE PROBLEM. THEY DO NOT SUSPECT THE VENT MALFUNCTIONING BUT WOULD LIKE TO KNOW IF INFO SUCH AS ALL THE CHANGES AND KEYSTROKES OVER THE LAST 48 HRS CAN BE RETRIEVED. EXPLAINED THAT THEY CANNOT, THE ERROR LOG AND TREND SCREEN WILL BE THE AREAS TO GET ANY INFO. HE SAID HE ALREADY CHECKED THE TRENDS AND THAT THERE WAS NOTHING SIGNIFICANT THERE. HE ALSO CHECKED THE ERROR LOG AND FOUND NO NEW ERRORS PRESENT. HE TALKED WITH HIS BOSS AND THEY WOULD LIKE A BILLABLE SRVC CALL TO HAVE SOMEONE COME OUT AND DO A COMPLETE CHECK OUT OF THE VENT TO DOCUMENT THAT ALL VENT FUNCTIONS ARE WORKING CORRECTLY". THE FOLLOWING ADD'L INFO CONCERNING THE EVENT WAS COPIED FROM A FAX RECEIVED FROM THE USER FACILITY ON (B)(6) 2011 THAT WAS IN RESPONSE TO A LETTER SENT BY CAREFUSION SEEKING ADD'L INFO. "EQUIPMENT BECAME DISCONNECTED DURING USE, UNK IF ALARMED, NO STAFF PRESENT STAFF CLAIMS THAT PT DISCONNECTED THEMSELVES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death