BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 2844953 · Received October 24, 2012

    Report

    Report Number
    2021710-2012-00096
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED AT (B)(6) HOSPITAL. THE FOREIGN DISTRIBUTOR DID NOT SUBMIT A USER FACILITY/IMPORTER REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION PROVIDED BY THE FOREIGN DISTRIBUTOR. (B)(4) THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION PROVIDED BY THE FOREIGN DISTRIBUTOR VIA E-MAIL AND INFORMATION PROVIDED BY THE CAREFUSION FAILURE ANALYSIS LAB TECHNICIAN. THE FOREIGN DISTRIBUTOR EVALUATED THE DEVICE AND IDENTIFIED A FAULTY TURBINE 3-PHASE MOTOR DRIVER AS THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT. THE FOREIGN DISTRIBUTOR REPLACED THE 3-PHASE MOTOR DRIVER AND REPORTED THAT UNIT WAS MEETING ALL FACTORY SPECS. THE FOREIGN DISTRIBUTOR RETURNED THE 3-PHASE MOTOR DRIVER TO THE CAREFUSION FAILURE ANALYSIS LAB IN A NON ESD (ELECTRO STATIC DISCHARGE) PACKAGE MATERIAL. SINCE THE 3-PHASE MOTOR DRIVER IS NOT MANUFACTURED BY CAREFUSION, IT WILL BE SENT TO THE MANUFACTURE FOR ROOT CAUSE ANALYSIS. ONCE WE RECEIVE ROOT CAUSE ANALYSIS FROM THE 3-PHASE MOTOR DRIVER MANUFACTURE, CAREFUSION WILL SUBMIT A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO AN E-MAIL FROM THE FOREIGN DISTRIBUTOR. "THE VENTILATION STOPPED, AND THE PATIENT SPO2 WAS DECREASED." THE FOLLOWING ADDITIONAL INFORMATION CONCERNING THE EVENT WAS COPIED FROM AN E-MAIL ATTACHMENT RECEIVED FROM THE FOREIGN DISTRIBUTOR ON (B)(4) 2012 THAT WAS IN RESPONSE TO AN E-MAIL SENT BY CAREFUSION SEEKING ADDITIONAL INFORMATION. "A NURSE FOUND OUT THE PATIENT SPO2 DECREASED ABOUT 40 WITH LOW PIP ALARM. THE TURBINE SEEMED NOT WORKING AT ALL. THE PATIENT IS STILL ON VENTILATOR SUPPORT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 F AND P MR850 HUMIDIFIER