BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 1972620 · Received January 14, 2011

    Report

    Report Number
    2021710-2011-00003
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K950484
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A CAREFUSION FIELD SERVICE REP AND WAS DOCUMENTED BY A CAREFUSION FIELD SERVICE REP IN RESPONSE TO A FACE TO FACE CONVERSATION WITH A BY THE USER FACILITY REP AND WRITTEN RESPONSES FROM THE USER FACILITY TO AN E-MAIL SENT BY CAREFUSION SEEKING ADDITIONAL INFO. (B)(4): THE FOLLOWING INFO CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP AND INFO SUPPLIED IN AN E-MAIL RECEIVED FROM THE USER FACILITY ON (B)(4) 2010 THAT WAS IN RESPONSE TO AN E-MAIL SENT BY CAREFUSION SEEKING ADDITIONAL INFO. THE CAREFUSION FIELD SERVICE REP EVALUATED THE DEVICE AND DID NOT FIND ANY PROBLEMS WITH THE DEVICE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAREFUSION FIELD SERVICE REP DID FIND THE FOLLOWING ISSUES WITH THE DEVICE; THE DUCKBILL CHECK VALVE PN: 03895, THE INLET CONE FILTER PN: 06804, AND THE TEFLON WASHER PN: 03808 WERE MISSING FROM THE LOWER O2 INLET ASSEMBLY. THE CAREFUSION FIELD SERVICE REP TESTED THE O2 REGULATOR (NOT MANUFACTURED OR SUPPLIED BY CAREFUSION) ATTACHED TO THE O2 TANK AND FOUND THAT THE REGULATOR DID NOT FUNCTION PROPERLY AND ALLOWED THE FULL PRESSURE OF THE TANK TO BE APPLIED TO THE TEST GAUGE. THE USER FACILITY DETERMINED THAT WHEN THE O2 TANK WAS OPENED, THE FULL PRESSURE OF THE TANK WAS TRANSMITTED TO THE HOSE WHICH RUPTURED DUE TO THE HIGH PRESSURE. THE USER FACILITY CONTACTED ECRI WHO SUGGESTED THAT HEAT COMPRESSION MIGHT HAVE CAUSED A SPARK AND THE RESULTING BURNING SMELL. BASED ON THE INFO SUPPLIED BY THE USER FACILITY AND THE EVALUATION OF THE DEVICE, CAREFUSION HAS DETERMINED THAT THE EVENT WAS CAUSED BY A MALFUNCTIONING O2 REGULATOR THAT WAS NOT MANUFACTURED OR SUPPLIED BY CAREFUSION.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTIONS OF THE EVENT WERE DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A CAREFUSION FIELD SERVICE REP AND WAS DOCUMENTED BY A CAREFUSION FIELD SERVICE REP IN RESPONSE TO A FACE TO FACE CONVERSATION WITH A BY THE USER FACILITY REP. "COMPLAINT CALLED IN BY FIELD SERVICE REP [NAME REMOVED], COMPLAINT REPORTED BY [NAME REMOVED] RESPIRATORY CARE MANAGER. ACCORDING TO [NAME REMOVED] DURING TRANSPORT O2 TANK WAS IN THE PROCESS OF BEING CHANGED AND THERE WAS A NOTED "SMALL EXPLOSION" ON THE BACK OF THE VENTILATOR BY O2 INLET. THE O2 HOSING WAS PHYSICALLY DAMAGED. THERE WAS NO HARM TO THE PT OR THE CAREGIVERS." "CUSTOMER REPORTED WHILE INSTALLING EXTERNAL OXYGEN TANK TO VENT THERE WAS AN EXPLOSION AT OXYGEN HOSE CONNECTING TO VENT. NO PT INJURY PER ([NAME REMOVED], RESPIRATORY DIRECTOR). CUSTOMER REQUESTED I INSPECT VENT AND DO NOT REPAIR." THE FOLLOWING ADDITIONAL INFO CONCERNING THE EVENT WAS COPIED FROM AN E-MAIL RECEIVED FROM THE USER FACILITY ON (B)(6) 2010 THAT WAS IN RESPONSE TO AN E-MAIL SENT BY CAREFUSION SEEKING ADDITIONAL INFO. "THE RT TURNED ON THE E OXYGEN CYLINDER CONNECTED TO THE T-BIRD TO TRANSPORT THE PT. A LOUD POP WAS FOLLOWED BY A FLASH, SMOKE AND A BURNING SMELL. THE PT WAS DISCONNECTED FROM THE VENT, MANUALLY VENTILATED AND REMOVED FROM THE ROOM. THERE WAS NO HARM TO THE PT OR STAFF. THE FIRE MARSHALL, BME AND RT MANAGERS WERE CALLED TO THE ROOM. INSPECTION OF THE E OXYGEN CYLINDER REGULATOR REVEALED THAT THE CYLINDER GAUGE WAS REPLACED WITH A 50PSI ADAPTER. WHEN THE CYLINDER WAS OPENED, FULL CYLINDER PRESSURE WAS TRANSMITTED TO THE HIGH PRESSURE HOSE. THE HOSE RUPTURED DUE THE HIGH PRESSURE. ECRI WAS CONTACTED AND SUGGESTED THAT HEAT COMPRESSION MIGHT HAVE CAUSED THE SPARK AND RESULTING BURNING SMELL. [NAME REMOVED] WAS ON SITE AND DETERMINED THAT THE VENTILATOR WAS NOT AFFECTED."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening