BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION

    MDR report key: 4374370 · Received December 18, 2014

    Report

    Report Number
    2021710-2014-00104
    Event Type
    Injury
    Date Received
    December 18, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 12, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BIOMED AT THE USER FACILITY EVALUATED THE VENTILATOR AND DETERMINED THAT REPLACEMENT OF THE MAIN POWER CONTROL BOARD FIXED THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VENTILATOR HAD MOTOR FAULT AND TRANSDUCER FAULT AND WENT INOPERABLE WHILE IN PT USE. NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835044 CAREFUSION CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention