BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIRD

    MDR report key: 2134983 · Received June 15, 2011

    Report

    Report Number
    2021710-2011-00033
    Event Type
    Death
    Date Received
    June 15, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K950484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION TECHNICAL SUPPORT HAS REQUESTED ON SEVERAL OCCASIONS THAT (B)(4) PROVIDE CAREFUSION WITH THE NAME, ADDRESS AND CONTACT INFORMATION OF THE FACILITY WHERE THE INCIDENT ACTUALLY OCCURRED. AS OF (B)(4) 2011, THEY HAVE NOT PROVIDED THAT INFORMATION. THE USER FACILITY, GENESIS REHABILITATION SERVICES, NOR (B)(4) SUBMITTED A USER FACILITY/IMPORTER REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION PROVIDED BY GENESIS REHABILITATION SERVICES. (B)(4): THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP. THE CARE FUSION FIELD SERVICE REP EVALUATED THE DEVICE AND FOUND THAT THE DEVICE OPERATED PER MANUFACTURER'S SPECIFICATIONS. UNRELATED TO THE REPORTED EVENT, THE CARE FUSION FIELD SERVICE REP FOUND A FEW SUPERFICIAL CRACKS IN THE EXTERNAL BATTERY TRAY WHICH DO NOT AFFECT THE OPERATION OF THE EXTERNAL BATTERY PACK. THE CAREFUSION FIELD SERVICE REP RAN THE DEVICE THROUGH A COMPLETE CHECKOUT TO ENSURE THAT IT MEETS ALL FACTORY SPECIFICATIONS. UPON COMPLETION, THE DEVICE WAS RETURNED TO (B)(4) CONTROL READY TO BE PLACED BACK INTO SERVICE. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS DID NOT FIND ANY LIKE INCIDENTS, THUS CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION CONCERNING THE EVENT WAS COPIED BY THE CAREFUSION TECH SUPPORT SPECIALIST FROM AN E-MAIL FROM A GENESIS REHAB SERVICES REPRESENTATIVE. "PATIENT DEATH ---". "INITIAL COMMENTS: THERE IS NO QUESTION AS TO WHETHER THE ALARM WAS GOING OFF. IT WAS SET AT THE CORRECT PRESSURE. THE FACILITY WOULD LIKE TO CONFIRM THAT THE ALARM SOUNDED IN A TIMELY FASHION WHEN THE UPPER LIMIT WAS REACHED. SPECIFICALLY, THE FACILITY IS MAINTAINING THAT THE NURSE RESPONDED IN A TIMELY MANNER TO THE ALARM BUT THAT THE PT "WAS BLUE" WHEN SHE ENTERED THE ROOM."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ASKU