BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 3854095 · Received May 12, 2014

    Report

    Report Number
    2021710-2014-00023
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 1, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, CAREFUSION SENT A LETTER VIA EMAIL TO THE USER FACILITY SEEKING ADDITIONAL INFO CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PT. AS OF (B)(4) 2014 THERE HAS BEEN RE RESPONSE FROM THE USER FACILITY. (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 THUS WAS NOT ABLE TO IDENTIFY A ROOT CAUSE IN THIS ALLEGED EVENT. THE CAREFUSION FIELD SERVICE REPRESENTATIVE PERFORMED A COMPLETE OPERATIONAL VERIFICATION PROCEDURE AND USER VERIFICATION TEST AND FOUND THE DEVICE PERFORMING TO FACTORY SPECIFICATIONS. UPON COMPLETION THE DEVICE WAS RETURNED TO THE CUSTOMER READY TO BE PLACED BACK INTO SERVICE. THE INABILITY TO VERIFY THE REPORTED EVENT HAS HAMPERED CAREFUSION'S ABILITY TO CONTINUE INVESTIGATING THIS ALLEGED EVENT. SHOULD ADDITIONAL INFO BECOME AVAILABLE 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 REPRESENTATIVE(S) ON (B)(6) 2014. "INTERMITTENT CIRCUIT DISCONNECT ALARM AND IT IS LOSING VOLUMES. NO DISPLAY OF VOLUMES." THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM A (B)(4) REPORT RECEIVED BY CAREFUSION FROM THE FDA ON (B)(4) 2014. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283237 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU