BEUDAMED
    FDA Adverse Event Death Summary report: N

    BEAR

    MDR report key: 2793778 · Received October 12, 2012

    Report

    Report Number
    2021710-2012-00091
    Event Type
    Death
    Date Received
    October 12, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 2, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K992788
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFO CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FACTORY SERVICE REPRESENTATIVE. THE CAREFUSION SERVICE REPRESENTATIVE EVALUATED THE DEVICE, VERIFIED THE COMPLAINT AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY PEEP VALVE. THE CAREFUSION SERVICE REPRESENTATIVE REPLACED THE PEEP VALVE AND RAN THE DEVICE THROUGH A COMPLETE CHECKOUT TO ENSURE IT MEETS ALL FACTORY SPECS. UPON COMPLETION THE DEVICE WAS RETURNED TO THE CUSTOMER READY TO BE PLACED BACK INTO SERVICE. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS RESULTED IN ZERO LIKE FAILURES, THUS A PRESENT CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST I RESPONSE TO A PHONE CONVERSATION WITH USER FACILITY REPRESENTATIVE ON (B)(4) 2012. "PEEP LEVEL IS NOT STABLE. PLEASE TEST AND REPAIR. CALL WITH ESTIMATE". ON (B)(4) 2012 DURING A PHONE CONVERSATION BETWEEN A CAREFUSION SERVICE DEPARTMENT REPRESENTATIVE AND A USER FACILITY REPRESENTATIVE, CAREFUSION BECAME AWARE THAT THIS DEVICE WAS INVOLVED IN A PT EXPIRATION. THE FOLLOWING ADDITIONAL INFO CONCERNING THE EVENT WAS COPIED FROM AN E-MAIL ATTACHMENT RECEIVED FROM THE USER FACILITY ON (B)(4) 2012 THAT WAS IN RESPONSE TO AN E-MAIL SENT BY CAREFUSION SEEKING ADDITIONAL INFO ON (B)(4) /2012. "AT A FLOW OF 8 AND AN INSP RATE OF 9, COULD NOT MAINTAIN PEEP ABOVE 4 CMH20. UNIT DID ALARM PER RESP. STAFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAR VENTILATOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION CUB 750PSV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death BUNNELL JET VENT: S/N (B)(4)