BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 4544410 · Received February 12, 2015

    Report

    Report Number
    2021710-2015-00277
    Event Type
    Malfunction
    Date Received
    February 12, 2015
    Date of Event
    January 15, 2015
    Report Date
    January 15, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOREIGN DISTRIBUTOR DETERMINED THAT THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS A FAULTY FRONT PANEL ASSEMBLY. THE FOREIGN DISTRIBUTOR WAS SHIPPED A REPLACEMENT FRONT PANEL ASSEMBLY TO REPAIR THE DEVICE AND RETURN IT TO SERVICE. CAREFUSION ISSUE A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE FOREIGN DISTRIBUTOR FOR THE RETURN OF THE ALLEGED FAULTY FRONT PANEL ASSEMBLY FOR EVALUATION. AS OF 02/112/2015 THE ALLEGED FAULTY FRONT PANEL ASSEMBLY HAS NOT BEEN RECEIVED. ONCE THE ALLEGED FAULTY FRONT PANEL ASSEMBLY IS RECEIVED AND THE EVALUATION IS COMPLETE, CAREFUSION WILL SUBMIT A FOLLOW-UP MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS: THE VELA FRONT PANEL (B)(4) WAS RECEIVED ON RGA 47986 AND ROUTED TO THE CAREFUSION FAILURE ANALYSIS LAB FOR EVALUATION. THE FRONT PANEL WAS VISUALLY INSPECTED AND PATCHES OF WHAT LOOKS LIKE FLUID INGRESS WERE FOUND. INSTALLED THE FRONT PANEL INTO A KNOWN GOOD UNIT (B)(4) AND PERFORMED TOUCH SCREEN CALIBRATION PER SERVICE MANUAL L2859-101 WHICH FAILED. THE TOUCH SCREEN IS INACTIVE, COULD NOT EVEN ACCESS THE CALIBRATION MENU. REPORTED PROBLEM WAS DUPLICATED. FINDINGS/ROOT CAUSE. REPORTED PROBLEM WAS DUPLICATED AND ISOLATED TO THE TOUCH SCREEN (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECHNICAL SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A FOREIGN DISTRIBUTOR'S REPRESENTATIVE. "NO PT INVOLVEMENT THERE IS SOME LIQUID SPOTS ON TOUCH SCREEN AND SCREEN IS NOT WORKING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103661 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA