BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIASYS

    MDR report key: 1978629 · Received January 24, 2011

    Report

    Report Number
    2021710-2011-00004
    Event Type
    Death
    Date Received
    January 24, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, CAREFUSION SENT AN E-MAIL TO THE USER FACILITY SEEKING ADD'L INFO CONCERNING THE REPORTED EVENT AND THE PT. AS OF JANUARY 19, 2011 THE USER FACILITY HAS NOT RESPONDED WITH THE REQUESTED INFO. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORTED 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. (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. ARRIVED AT THE USER FACILITY AND FOUND THAT THE USER FACILITY HAD ALREADY CHECKED THE DEVICE AND HAD ALREADY USED IT ON ANOTHER PT PRIOR TO HIS ARRIVAL. 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 USER FACILITY REPRESENTATIVE(S). "PT DIED. THEY DO NOT FEEL IT IS A RESULT OF THE VENTILATOR AS THE PT'S HEART STOPPED BUT THE VENTILATOR KEPT WORKING AS IT WAS SET WITH NO PROBLEM. THE DIRECTOR OF RESP THERAPY IS [NAME REMOVED] AND HE TESTED IT RIGHT AFTER THE EVENT AND IT WORKED WELL WITH NO PROBLEMS. THEY WOULD LIKE FIELD SERVICE TO COME OUT AND CHECK IT THOROUGHLY AND PULL THE CODES AND MAKE SURE IT IS OPERATING PROPERLY. AGAIN THEY DO NOT BELIEVE ANYTHING IS WRONG WITH THE VENT AND THEY DO NOT THINK IT CONTRIBUTED TO THE PT'S DEATH."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ASKU/ASKU