BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 2096149 · Received May 12, 2011

    Report

    Report Number
    2021710-2011-00034
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. (B)(4). THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP AND THE CAREFUSION FAILURE ANALYSIS LAB TECH. THE CAREFUSION FIELD SERVICE REP EVALUATED THE DEVICE, VERIFIED THE COMPLAINT AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED AUDIBLE ALARM NOT WORKING WAS A FAULTY GAS DELIVERY ENGINE. THE CAREFUSION FIELD SERVICE REP REPLACED THE GAS DELIVERY ENGINE. ADDITIONALLY, THE CAREFUSION FIELD SERVICE REP REPLACED THE INTERNAL BATTERY AS A PRECAUTION AND RAN THE DEVICE THROUGH A COMPLETE CALIBRATION AND CHECKOUT TO ENSURE THAT IT MEETS ALL FACTORY SPECS. UPON COMPLETION, THE DEVICE WAS RETURNED TO THE CUSTOMER'S CONTROL READY TO BE PLACED BACK INTO SERVICE. THE CAREFUSION FAILURE ANALYSIS LAB TECH EVALUATED THE GAS DELIVERY ENGINE AND VERIFIED THE COMPLAINT OF THE AUDIBLE ALARM NOT SOUNDING. THE CAREFUSION FAILURE ANALYSIS LAB TECH DETERMINED THAT THE ROOT CAUSE OF THE GAS DELIVERY ENGINE'S FAILURE WAS A FAULTY IC ON THE TRAN COM ALARM (TCA) PCBA. CAREFUSION HAS INITIATED AN INTERNAL CORRECTIVE ACTION REQUEST THROUGH OUR CORRECTIVE AND PREVENTATIVE ACTION SYSTEM TO ADDRESS THIS ISSUE.

    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 REP: "CUSTOMER CLAIMS, THE AUDIBLE ALARM IS NOT WORKING ON THIS VENTILATOR, IF THEY CREATE AN ALARM SITUATION THEY ONLY GET THE VISUAL ALARM BUT NOT AUDIBLE. THEY ALSO CLAIM THE INTERNAL BATTERY IN THIS VENTILATOR IS CHARGED AT THE BATTERY INDICATOR IS ON RED."

    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 NA