BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEA VENTILATOR

    MDR report key: 5171771 · Received October 23, 2015

    Report

    Report Number
    2021710-2015-01983
    Event Type
    Injury
    Date Received
    October 23, 2015
    Date of Event
    September 23, 2015
    Report Date
    September 23, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS (FA) REPRESENTATIVE (REP) INSTALLED THE UIM (USER INTERFACE MODULE) ASSEMBLY ONTO THE AVEA TEST STATION. THE CAREFUSION FA REP POWERED UIM IN TO USER MODE AND THE TOUCH SCREEN WAS RESPONDING PROPERLY. THE CAREFUSION FA REP CYCLED THE POWER IN TO SERVICE MODE AND SUCCESSFULLY RECALIBRATED THE TOUCH SCREEN. THE CAREFUSION FA REP THEN PROCEEDED BY CONSTANTLY SWITCHING TO DIFFERENT VENTILATION MODES IN NEONATAL, PEDIATRIC AND ADULT PATIENTS IN USER MODE. THE CAREFUSION FA REP CONTINUED BY ADJUSTING SETTINGS WHILE THE UNIT WAS CYCLING. THE CAREFUSION FA REP ALLOWED THE UIM TO CYCLE FROM FOR A TOTAL OF ONE-HUNDRED-FOURTEEN HOURS, AFTER THE CYCLING WAS COMPLETE THE UIM WAS STILL OPERATING PROPERLY. THE CAREFUSION FA REP DISASSEMBLED THE UIM TO INSPECT PCB¿S (PRINTED CIRCUIT BOARD), CABLES AND CONNECTORS, DID NOT FIND ANY ANOMALIES. THE CAREFUSION FA REP WAS UNABLE TO DUPLICATE THE REPORTED ISSUE AND NO KNOWN ROOT-CAUSE WAS DETERMINED. AS A PRECAUTIONARY MEASURE THE CAREFUSION FA REP REPLACED THE DISPLAY ASSEMBLY.

    Additional Manufacturer Narrative · 1

    (B)(6). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, GENDER, AND WEIGHT. ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. (B)(4). THE SUSPECT DEVICE HAS NOT BEEN RECEIVED BY CAREFUSION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TOUCHSCREEN DISPLAY WAS NOT RESPONDING WHILE USING THE AVEA VENTILATOR. THE NONRESPONSIVE TOUCHSCREEN OCCURRED DURING PATIENT USE, AND THE CUSTOMER STATED, "THE VENTILATOR WAS NOT VENTILATING." CAREFUSION (CFN) TECHNICAL SUPPORT IN CONJUNCTION WITH CFN CUSTOMER ADVOCACY, REQUESTED ADDITIONAL INFORMATION REGARDING IF ANY ALARMS WERE PRESENT WHEN THESE ISSUES OCCURRED. THE CUSTOMER REPORTED THE PATIENT WAS REMOVED FROM THE SUSPECT DEVICE AND PLACE ON ANOTHER WORKING VENTILATOR, AND NO KNOWN PATIENT IMPACT OR CONSEQUENCE IS ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700732 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention