BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 2854953 · Received November 26, 2012

    Report

    Report Number
    2021710-2012-00109
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    July 23, 2012
    Report Date
    July 23, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K022674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE BY THE USER FACILITY WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP ON (B)(4) 2012. "FOLLOWED WITH BIOMED [NAME REMOVED] AND HE STATED HE DID CHANGE THE EX FLOW RECEPTACLE WITHOUT RESOLVE. AT THIS TIME, THEY OPTED TO HAVE THE VENTILATOR EVALUATED BY A THIRD PARTY BIOMED, BIO-ONE. IT IS STILL IN ITS EVAL PHASE. [NAME REMOVED] ALSO STATED WHEN THE INCIDENT WAS REPORTED THERE WAS NO HARM TO THE PT. RESPIRATORY WAS AT THE BEDSIDE AND WAS IMMEDIATELY REMOVED FROM THIS VENTILATOR." SHOULD CAREFUSION OBTAIN A COPY OF THE THIRD PARTY SERVICE COMPANY EVAL REPORT, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    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) ON (B)(6) 2012. "[NAME REMOVED] CALLED STATING THIS VENTILATOR WAS DISPLAYING CIRCUIT OCCLUSION ALARM. UPON INSPECTION, HE FOUND THE EX FLOW RECEPTACLE WAS DAMAGED. PROVIDED [EXHALED FLOW SENSOR RECEPTACLE] P/N (B)(4)."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 DA ASKU