BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 2250918 · Received September 12, 2011

    Report

    Report Number
    2021710-2011-00070
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K031745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CAREFUSION FACTORY SERVICE REP. THE CAREFUSION FACTORY SERVICE REP EVALUATED THE DEVICE, VERIFIED THEE COMPLAINT OF "SCREEN IS CRACKED" AND DETERMINED THAT THE FRONT PANEL ASSEMBLY WOULD NEED TO BE REPLACED IN ORDER TO REPAIR THE DEVICE. THE CAREFUSION FACTORY SERVICE REP WAS UNABLE TO DETERMINE WHAT CAUSED THE CRACK IN THE SCREEN. THE CAREFUSION FACTORY SERVICE REP REPLACED THE FRONT PANEL ASSEMBLY AND RAN THE DEVICE THROUGH A COMPLETE CALIBRATION AND CHECKOUT TO ENSURE THAT IT MEETS ALL FACTORY SPECIFICATIONS. UPON COMPLETION OF THE DEVICE WAS RETURNED TO THE USER FACILITY READY TO BE PLACED BACK INTO SERVICE. NOTE: THE DEVICE WAS RECEIVED BY CAREFUSION ON 06/24/2011 WITH THE ONLY REPORTED PROBLEM BEING "THE SCREEN IS CRACKED." THERE WAS NO MENTION AT THAT TIME OF ANY PATIENT INVOLVEMENT OR ANY INABILITY TO CHANGE MODES. THUS THE DEVICE WAS ONLY EVALUATED TO VERIFY THE CRACKED SCREEN AND RETURNED TO THE USER FACILITY ON 07/05/2011 FOLLOWING REPAIR. CAREFUSION RECEIVED THE UF/IMPORTER MEDWATCH REPORT FROM THE FDA ON 08/15/2011, 42 DAYS AFTER THE DEVICE WAS RETURNED TO THE USER FACILITY.

    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. "[NAME REMOVED] CALLED REQUESTING RMA TO SEND THIS DRIVER IN FOR REPAIR. PROBLEM: THE SCREEN IS CRACKED. (B)(4). (B)(6) NEEDS A BOX SO I WILL SEND THAT TO HIM. (B)(4)."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Other ASKU