BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIASYS

    MDR report key: 2265167 · Received September 20, 2011

    Report

    Report Number
    2021710-2011-00071
    Event Type
    Death
    Date Received
    September 20, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 2011
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K950484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE FOREIGN DISTRIBUTOR FOR THE RETURN OF THE ALLEGED FAULTY DEVICE FOR EVAL. PER FOREIGN DISTRIBUTOR THE USER FACILITY DIDN'T ASK FOR FURTHER ASSISTANCE AND WILL NOT BE RETURNING THE DEVICE FOR EVAL. THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE WAS COPIED FROM AN E-MAIL FROM THE FOREIGN DISTRIBUTOR'S RESPONSE TO A LETTER SENT BY CAREFUSION SEEKING ADDITIONAL INFO. "THE HOSPITAL DIDN'T ASK FOR OUR FURTHER ASSISTANCE AND IT IS THEIR BIOMED ENGINEER DEPARTMENT CURRENTLY TAKES CHARGE OF THE CAPTIONED VENTILATOR. WE HONESTLY HAVE NO ACCESS TO IT. OUR ENGINEER ONLY HAS ONE CHANCE TO TOUCH THE DEVICE ON (B)(6) AND HERE IS WHAT HAPPENED: ON (B)(6), I RECEIVED A SERVICE CALL AND WAS INFORMED THAT: THE WITNESS SAID SHE SAW THE VENT WASN'T VENTILATING AND DIDN'T GENERATE ANY ALARM. HEARD THE RT HAD RUN A UVT ON THIS VENT AND IT DID PASS. AFTER ARRIVAL, I INVESTIGATED THE VENT WITH THE HOSPITAL'S BIOMED ENGINEERS. THE HOSPITAL EVEN MADE A SHORT FILM TO RECORD THE WHOLE INVESTIGATION PROCESS. HERE IS WHAT HE DID: TURNED ON THE VENT AND CHECKED FOR EVENTS. THE BIOMED ENGINEER WROTE DOWN THE CODES. (THE VENT WAS ON AC POWER AT THIS TIME.) LET THE VENT WORKING ON THE SETTINGS PRESCRIBED FOR THAT PT FOR A WHILE. THE VENT WAS ACTUALLY FUNCTIONING NORMALLY AND ALARMS WERE GENERATED: 13:07 TURNED ON THE VENT (USING INTERNAL BATTERY); 13:08 ENTERED POWER-SAVING MODE; 14:17 THE CHARGE INDICATOR TURNED YELLOW. (AT THE SAME TIME, THE VENT GENERATED A "BI-BI-BI" ALARM); 14:50 THE CHARGE INDICATOR TURNED RED. (AT THE SAME TIME, THE VENT GENERATED A "BI----I" ALARM); 15:10 INTERNAL BATTERIES EXHAUSTED. THE VENT STOPPED VENTILATED BUT KEPT ALARMING; 15:20 ALARM STOPPED. OPENED THE OUTER SHELL OF THE VENT AND INSPECTED. THERE WAS NOTHING ABNORMAL EXCEPT DUSTS. THERE WERE DUSTS IN THE FAN FILTER AS WELL. INSTALLED BACK THE OUTER SHELL."

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM AN E-MAIL FROM THE FOREIGN DISTRIBUTOR IN (B)(4). "WE WERE INFORMED BY OUR CLIENT HOSPITAL, (B)(6) HOSPITAL, THAT ONE PT ON T-BIRD VENTILATOR WAS SURPRISINGLY FOUND DEAD THIS MORNING. (B)(6) AND THE PT'S FAMILY IS NOW TRYING TO LOCATE THE CAUSE OF DEATH, AND ASKED OUR ENGINEERS TO INVESTIGATE THE MACHINE. AN ERROR CODE 251 WAS APPEARED ONE HOUR BEFORE THE PT PASSED AWAY. THE VENT WAS FOUND USING THE INTERNAL BATTERY AT THE END WHILE IT WAS CONNECTED TO THE AC POWER. THAT IS, THE VENT SWITCHED FROM AC TO INTERNAL BATTERY AUTOMATICALLY, WITHOUT REASONS. AS THE ERROR CODE 251 REPRESENTS AN OVERT-HEATING ON THE POWER SUPPLY, THE HOSPITAL WOULD LIKE TO KNOW IF IT IS A RATIONAL ASSUMPTION THAT THIS OVER-HEATING MADE THE VENT AUTOMATICALLY SWITCH FROM AC POWER SUPPLY TO INTERNAL BATTERY. ACCORDING TO THE NURSING STAFF, AT THE MOMENT THEY FOUND THE PT'S FACE TURNED BLACK, THE VENT WAS NOT WORKING. LATER ON, THEY FOUND THE INTERNAL BATTERY WAS EXHAUSTED AND IT SEEMED LIKE THE VENT HAD SWITCHED FROM AC TO DC AND WORKED ON THE INTERNAL BATTERY TILL THE BATTERY WAS EXHAUSTED. THE NURSING STAFF ALSO CLAIMS THEY DIDN'T HEAR ANY ALARMS. OUR ENGINEERS AND THE HOSPITAL'S BIOMED ENGINEERS MADE A FULL INVESTIGATION ON THIS VENT AND FOUND...

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ASKU