BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 4945155 · Received July 24, 2015

    Report

    Report Number
    2021710-2015-01265
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    June 26, 2015
    Report Date
    June 26, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION HAS REQUESTED CLARIFICATION VIA EMAIL FROM THE DISTRIBUTOR IN (B)(4) ON THE REPORTED EVENT AND STATUS OF THE PATIENT. AS OF JULY 24, 2015 THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED BY THE USER FACILITY PERTAINING TO THAT REQUEST. THE DISTRIBUTOR IN (B)(4) DETERMINED THAT THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS THAT THE DEVICE'S POWER SUPPLY WAS MALFUNCTIONING. AT PRESENT CAREFUSION IS IN THE PROCESS OF MAKING ARRANGEMENTS TO SEND A REPLACEMENT POWER SUPPLY TO REPAIR THE DEVICE AND HAVE THE ALLEGED FAULTY POWER SUPPLY RETURNED TO THE CAREFUSION FAILURE ANALYSIS LAB FOR EVALUATION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR IN (B)(4) REPORTED THAT WHILE IN USE ON A PATIENT THE DEVICE'S POWER SUPPLY FAILED. THE PATIENT WAS REMOVED FROM THE DEVICE AND PLACED ON ANOTHER DEVICE WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482594 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention