BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIASYS

    MDR report key: 4374294 · Received December 19, 2014

    Report

    Report Number
    2021710-2014-00107
    Event Type
    Injury
    Date Received
    December 19, 2014
    Date of Event
    November 13, 2014
    Report Date
    November 13, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K081837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE COMPLETION OF FDA AUDIT ON (B)(4) 2014, CAREFUSION (B)(4) HAS REVISED THE MDR PROCEDURES. THIS COMPLAINT WAS DETERMINED TO BE REPORTABLE PER THE REVISED PROCEDURES. THE USER FACILITY DID NOT SUBMITTED 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 EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP. THE CAREFUSION FIELD SERVICE REP EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY THE REPORT OF THE DEVICE ALARMING 'VENT INOP". HOWEVER DURING THE EVALUATION OF THE DEVICE, THE CAREFUSION FIELD SERVICE REP OBSERVED THAT THE DEVICE'S VTE READING WAS UNSTABLE. THE CAREFUSION FIELD SERVICE REP DETERMINED THAT THE CAUSE OF THE UNSTABLE VTE READINGS WAS A FAULTY GAS DELIVERY ENGINE (GDE). THE CAREFUSION FIELD SERVICE REP REPLACED THE GAS DELIVERY ENGINE (GDE) AND RAN THE DEVICE THROUGH A COMPLETE OPERATIONAL CHECKOUT PER THE SERVICE MANUAL TO ENSURE THAT THE DEVICE MEETS FACTORY SPECIFICATIONS. THE ALLEGED FAULTY GAS DELIVERY ENGINE (GDE) HAS BEEN RECEIVED AND ROUTED TO THE CAREFUSION FAILURE ANALYSIS LAB FOR EVALUATION. ONCE THE EVALUATION IS COMPLETE, 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 A USER FACILITY REP. "CUSTOMER CLAIMS THIS VENTILATOR WAS ALARMING "VENT INOP" WHILE ON A PT, THEY CLAIM THE THERAPIST WAS WITH THE PT WHEN THE PROBLEM OCCURRED, THE VENTILATOR WAS REMOVED FROM THE PT AND THE PT WAS PLACED ON ANOTHER VENTILATOR. THEY CLAIM THERE WAS NO HARM DONE TO THE PT, ACCORDING TO THE CUSTOMER THIS IS THE SECOND TIME THIS ALARM CAME ON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838219 VIASYS VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention