BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION

    MDR report key: 4290758 · Received November 17, 2014

    Report

    Report Number
    2021710-2014-00070
    Event Type
    Injury
    Date Received
    November 17, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 23, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION PROVIDED BY THE USER FACILITY VIA PHONE CONVERSATION(S) AND INFORMATION CONTAINED ON THE MAUDE EVENT REPORT RECEIVED FROM THE FDA. (B)(4). CAREFUSION HAS IDENTIFIED THAT THE CORRECT DEVICE SERIAL NUMBER FOR THIS EVENT IS SERIAL NUMBER (B)(4) AND NOT (B)(4) AS DOCUMENTED IN THE MAUDE EVENT REPORT. THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CAREFUSION FIELD SERVICE REPRESENTATIVE. THE CAREFUSION FIELD SERVICE REPRESENTATIVE EVALUATED THE VENTILATOR AND FOUND MISSING FLOW SENSOR RECEPTACLE COVER AND O-RING WHICH WAS CAUSING LOW VTE. CAREFUSION TECHNICAL SUPPORT IS CONTACTING THE CUSTOMER TO REVIEW PROPER HANDLING AND MAINTENANCE OF THE FLOW SENSOR RECEPTACLE COVER AND O-RING.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT IS A SUMMARY OF THE INFORMATION DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "CUSTOMER CLAIMS THIS VENTILATOR HAS A SENSOR ISSUE, THIS IS ALL THE INFORMATION PROVIDED TO THEM. CUSTOMER IS REQUESTING FOR FIELD SERVICE TO COME IN AND CORRECT THIS PROBLEM." THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM A MAUDE EVENT REPORT RECEIVED BY CAREFUSION FROM THE FDA ON (B)(4) 2014. REFERENCE VOLUNTARY REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743535 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention PULSE OXIMETER