BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 3040345 · Received March 12, 2013

    Report

    Report Number
    2021710-2013-00015
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT 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(S) WITH A USER FACILITY REPRESENTATIVE AND INFO PROVIDED BY THE USER FACILITY IN A WRITTEN RESPONSE TO A LETTER FROM CAREFUSION SEEKING ADDITIONAL INFO. (B)(4). THE FOLLOWING INFO CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FIELD SERVICE REPRESENTATIVE. THE CAREFUSION FIELD SERVICE REPRESENTATIVE EVALUATED THE DEVICE AND WAS NOT ABLE TO REPRODUCE THE REPORTED FAILURE. THEREFORE WE WERE NOT ABLE TO IDENTIFY A ROOT CAUSE IN THIS ALLEGED EVENT. THE UNIT WAS RETURNED TO CAREFUSION FACTORY SERVICE DEPARTMENT FOR FURTHER EVALUATION. THE ALLEGED FAULTY UNIT WAS RECEIVED BY CAREFUSION ON (B)(4) 2013 AND STAGED FOR EVALUATION. ONCE THE EVALUATION IS COMPLETE A FOLLOW-UP MEDWATCH 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 USER FACILITY REPRESENTATIVE(S) ON (B)(6) 2013. "VENT MONITOR WENT TO ALL VERTICAL LINES AND STOPPED VENTILATING, NO GAS BEING, NO VENT ALARMS SEEN OR HEARD. NO HARM TO PT, VENT WAS PULLED AND TAKEN TO BIOMED." THE FOLLOWING ADDITIONAL INFO CONCERNING THE EVENT WAS COPIED FROM A LETTER RECEIVED VIA FAX FROM THE USER FACILITY ON (B)(6) 2013 THAT WAS IN RESPONSE TO A LETTER SENT BY CAREFUSION SEEKING ADDITIONAL INFO. ON "(B)(6) 2013 "VENT MONITOR SCREEN WENT TO DASHING LINES AND VENT STOPPED "VENTILATING". NO AIR WAS COMING FROM THE VENT AT ALL. NO VENTILATOR ALARMS SEEN OR HEARD. ALL VENTILATOR MONITOR SCREENS SHOWED - (LINES ACROSS)." (THESE WERE NOT DASHED LINES IN THE ALPHA/NUMERIC FIELDS, BUT DEASHED LINES ACROSS THE DISPLAY THAT MADE IT UNREADABLE. PT WAS PLACED ON ANOTHER AVEA VENT WITHOUT INCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104385 VIASYS VENTILATOR, CONTINUOUS, FACTILITY USE/CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO ASKU