BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIASYS

    MDR report key: 2895347 · Received November 29, 2012

    Report

    Report Number
    2021710-2012-00111
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K022674
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 AND WAS UNABLE TO REPRODUCE THE REPORTED EVENT. THE CAREFUSION FIELD SERVICE REP REPLACED THE GAS DELIVERY ENGINE (GDE) AS A PRECAUTION AS THE UNIT HAD DISPLAYED THE "EXT HIGH PEAK" ALARM ON SEVERAL OCCASIONS. THE CAREFUSION FIELD SERVICE REP THEN PERFORMED A COMPLETE CALIBRATION AND TESTING OF THE DEVICE PER THE PROCEDURES IN THE AVEA SERVICE MANUAL. UPON COMPLETION THE DEVICE WAS RETURNED TO THE USER FACILITY'S CONTROL READY TO BE PLACED BACK INTO SERVICE. THE GAS DELIVERY ENGINE (GDE) WAS RECEIVED INTO THE CAREFUSION FAILURE ANALYSIS LAB FOR EVAL. THE CAREFUSION FAILURE ANALYSIS LAB TECH INSTALLED THE GAS DELIVERY ENGINE (GDE) INTO A TEST UNIT, POWERED IT ON AND DID NOT FIND ANY VENT-INOP CONDITION OR ANY AUDIBLE OR VISUAL ALARMS SHOWING. THE EXTENDED SYSTEMS TEST (EST) WAS PERFORMED, ALL TEST PASSED AND NO LEAKS WERE FOUND. UTILIZING THE NEONATAL MODE DEFAULT SETTINGS, THE UNIT WAS CYCLED TO TRY AND DUPLICATE THE REPORTED ISSUE. AFTER CYCLING THE TEST UNIT FOR 48 HOURS THE CAREFUSION FAILURE ANALYSIS LAB TECH WAS UNABLE TO REPRODUCE/VERIFY THE REPORTED ISSUE. A CONTRIBUTING FACTOR MAY HAVE BEEN A WET OR CLOGGED EXPIRATORY FILTER DUE TO INCREASED CONDENSATION IN THE PT CIRCUIT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED ON (B)(6) 2012 BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "[NAME REMOVED] BIOMED CALLED NOTING UNIT WAS REFERRED BY RESPIRATORY DEPT DUE TO WHILE IN PT USE THE UNIT DISPLAYED EXT HIGH PEAK" THE AUDIBLE ALARM WAS PRESENT SETTINGS AT THE TIME, PRESSURE AC NEO MODE RR 20, INSPIRATORY PRESSURE 13, PEEP 5, FIO2 21% ITIME .35. NO PT HARM NOTED, PT WAS PLACED ON ANOTHER UNIT. THE CUSTOMER IS REQUESTING ONSITE SERVICE, THE CUSTOMER NOTES THE UNIT WAS SERVICED LAST MONTH FOR THE SAME ISSUE (CALL #(B)(6)) I WILL DISPATCH FSR. THE BIOMED HAS CYCLED THE UNIT FOR A FEW HOURS HE HAS NOT DUPLICATED THE ISSUE."

    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 25 DA Other ASKU