BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION

    MDR report key: 5065722 · Received September 9, 2015

    Report

    Report Number
    2021710-2015-01589
    Event Type
    Death
    Date Received
    September 9, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 12, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY WAS RETURNED TO CAREFUSION FOR INVESTIGATION. CAREFUSION FAILURE ANALYSIS LAB EVALUATED THE DEVICE, AND ON POWER-UP NOTICED MULTIPLE ERROR CODES IN THE EVENT LOG NAMELY: ¿POST DAC OR ADC ERROR AND 24V POWER SUPPLY VOLTAGE LOW¿. THE UNIT WAS ALSO ALARMING VENT INOP. THE MAIN PRINTED CIRCUIT BOARD WAS REMOVED AND THE RESISTOR WAS REPLACED WITH A NEW ONE. ONCE THE RESISTOR WAS REPLACED, THE ISSUE RESOLVED, AND THERE WERE NO OTHER ANOMALIES. FINDINGS/ROOT-CAUSE: REPORTED PROBLEM WAS DUPLICATED AND ISOLATED TO A BAD RESISTOR.

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED BY A DISTRIBUTOR IN (B)(4). THE DISTRIBUTOR REPORTED THE FOLLOWING : "THE HOSPITAL STAFF CALLED IN IMI FIELD SERVICE THAT VENT INOP WENT OFF DURING PATIENT USE .(SW 03.02.00) 10:00AM, START SURGERY IN THE HYBRID OPERATING ROOM, THE PATIENT WAS ON PCPS. 10:13AM, CIRCUIT DISCONNECT AND O2 RANGE ERROR WENT OFF. 10:15AM, VENT INOP WENT OFF, AND THE DOCTOR HAS SUBSTITUTED THIS TO ANESTHESIA MACHINE FOR VENTILATION. (B)(6) 2015: WE WERE TOLD THE PATIENT PASSED AWAY AFTER THE INCIDENT, BUT THEY ASSUME THERE IS NO RELATIONSHIP BETWEEN PATIENT DEATH AND THIS INCIDENT. HOWEVER THEY ARE WILLING TO REPORT THIS TO (B)(4). (B)(6) 2015 INCIDENT REPORT WAS REPORTED TO (B)(4) BY THE HOSPITAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594447 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION VELA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death