BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3192400 · Received June 18, 2013

    Report

    Report Number
    2031702-2013-00135
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    DURING BENCH TESTING, THE FIELD SERVICE TECHNICIAN REPORTED THAT THE VENTILATOR'S TURBINE WOULD INTERMITTENTLY NOT SPIN EVERY 5 TO 7 POWER-UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276272 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC. LTV 1150 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA