BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION

    MDR report key: 2781963 · Received October 4, 2012

    Report

    Report Number
    2021710-2012-00087
    Event Type
    Death
    Date Received
    October 4, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 10, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2012, CAREFUSION SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFO CONCERNING THE REPORTED EVENT, THE CONDITION OF THE PT AND THE REPAIR OF THE DEVICE. AS OF THE OCTOBER 3, 2012 THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. SHOULD ADDITIONAL INFO BECOME AVAILABLE OR IF THE UNIT BECOMES AVAILABLE FOR EVALUATION CAREFUSION WILL SUBMIT A FOLLOW-UP MEDWATCH REPORT.

    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). "[NAME REMOVED] CALLED THE AFTER HOURS PHONE TO REPORT AN INCIDENT ON A PT WITH THIS UNIT THAT OCCURRED ON (B)(6) 2012. UNK VENTILATOR SETTINGS. NURSES WERE ALERTED TO AN ISSUE WITH THE PT WHEN THE PULSE OXIMETER WAS ALARMING. WHEN THEY WENT TO THE ROOM, THE SCREEN ON THE VENTILATOR WAS BLANK AND THE UNIT WAS NOT VENTILATING, UNK IF VENTILATOR WAS ALARMING, ONLY ALARM NOTED TO BE GOING OFF BY STAFF WAS ON A PULSE OXIMETER. STAFF TOOK PT OFF OF VENTILATOR AND BEGAN HAND VENTILATING AND HR AND PULSE OXIMETER INITIALLY WENT UP BUT DROPPED AGAIN AND RT WAS NOTIFIED AND CPR BEGAN, PT SUBSEQUENTLY DIED. RT STAFF TRIED TO GET UNIT TO WORK BY TURNING UNIT ON AND OFF WITH POWER SWITCH AND NOTHING HAPPENED ON VENTILATOR. UNIT IS NOW SEQUESTERED IN [NAME REMOVED] OFFICE AND HAS NOT BEEN TOUCHED PER [NAME REMOVED] POLICY. [NAME REMOVED] WILL CONDUCT OWN INTERNAL INVESTIGATION AND THEN WILL LET US KNOW WHEN WE CAN COME IN AND SERVICE THE UNIT." THE FOLLOWING DESCRIPTION OF THE EVENT AND THE CONDITION OF THE PT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CAREFUSION FROM THE USER FACILITY ON (B)(6) 2012. "VENTILATOR WAS NOT WORKING. THE VENTILATOR SCREEN WAS BLACK. PT PULSE OXYGENATION DROPPED AND THE STAFF RESPONDED TO THE PULSE OXIMETER ALARM TO FIND THE VENTILATOR NOT WORKING."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death ASKU