BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 3174356 · Received June 7, 2013

    Report

    Report Number
    2021710-2013-00045
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    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 DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION(S) WITH A USER FACILITY REPRESENTATIVE. (B)(4). THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE BY THE USER FACILITY WAS DOCUMENTED BY THE CAREFUSION FIELD SERVICE REPRESENTATIVE. THE CAREFUSION FIELD SERVICE REPRESENTATIVE EVALUATED THE DEVICE AND DETERMINED THAT THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY USER INTERFACE MODULE. THE CAREFUSION FIELD SERVICE REPRESENTATIVE REPLACED THE USER INTERFACE MODULE, PERFORMED A PREVENTATIVE MAINTENANCE 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. UPON RECEIPT INTO THE CAREFUSION SERVICE DEPARTMENT, THE ALLEGED FAULTY USER INTERFACE MODULE WAS VISUALLY INSPECTED AND RUN FOR SEVERAL DAYS WITHOUT ANOMALIES. THE ALLEGED FAULTY USER INTERFACE MODULE HAD NO ADVERSE EFFECT ON ANY OF THE ALARM CONDITIONS. AFTER THE RUN-IN PERIOD, THE CAREFUSION SERVICE REPRESENTATIVE EVALUATED THE ALLEGED FAULTY USER INTERFACE MODULE AND WAS NOT ABLE TO REPRODUCE THE REPORTED FAILURE THUS WAS NOT ABLE TO IDENTIFY A ROOT CAUSE IN THIS ALLEGED EVENT. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS RESULTED IN ZERO LIKE EVENTS, THUS AT 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 IN RESPONSE TO A PHONE CONVERSATION WITH A CAREFUSION FIELD SERVICE REPRESENTATIVE. WHILE ONSITE PERFORMING PREVENTATIVE MAINTENANCE, CAREFUSION FIELD SERVICE REPRESENTATIVE [NAME REMOVED] FOUND THIS VENTILATOR HAD INTERMITTENT ALARM ISSUES. SOMETIMES IT WOULD ALARM APPROPRIATELY AND OTHERS JUST GIVE A VISUAL ALARM. AFTER TROUBLESHOOTING HE FOUND THE ISSUE TO BE THE USER INTERFACE MODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253691 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA