BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREFUSION

    MDR report key: 2477511 · Received February 23, 2012

    Report

    Report Number
    2021710-2012-00009
    Event Type
    Other
    Date Received
    February 23, 2012
    Date of Event
    January 27, 2012
    Report Date
    January 27, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. (B)(4). THE FOLLOWING INFO CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP. THE CAREFUSION FIELD SERVICE REP EVALUATED THE DEVICE AND WAS UNABLE TO REPRODUCE/VERIFY THE COMPLAINT. THUS NO ROOT CAUSE WAS DETERMINED. 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 THE CUSTOMER¿S CONTROL READY TO BE PLACED BACK INTO SERVICE. AS THE REPORTED EVENT COULD NOT BE REPRODUCED/VERIFIED AND NO ROOT CAUSE WAS DETERMINED, 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 IN RESPONSE TO A PHONE CONVERSATION WITH A CAREFUSION SALES REP. "SALES [NAME REMOVED] CALLED REQUESTING FSD ON BEHALF ON THE CUSTOMER NOTING THAT IT HAD BEEN REPORTED THAT THE UNIT WHILE IN PT USE. IN SIMV (VOLUME) MODE ADULT THE FLO2 WAS SET AT 100% THE UNIT DISPLAYED FLO2 OF 100% THE PT THOUGH WAS IN RESPIRATORY DISTRESS DUE TO O2 SATURATION DROPPING. THE RESPIRATORY THERAPIST APPARENTLY PLACED AN EXTERNAL O2 DROPPING. THE RESPIRATORY THERAPIST APPARENTLY PLACED AN EXTERNAL O2 ANALYZER UNIT FACILITY NEEDS ONSITE VISIT BY FSR TO EVALUATE THE UNIT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASKU