BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3953859 · Received July 23, 2014

    Report

    Report Number
    2031702-2014-00174
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    December 9, 2013
    Report Date
    July 23, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN VENTILATOR SWITCHED TO AN INTERNAL BATTERY, IT DID NOT OPERATE AND HAD NO AUDIBLE ALARM. THE EVENT OCCURRED IN THE HOSPITAL AND THE VENTILATOR WAS NOT CONNECTED TO A PATIENT. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431276 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1200

    Patients

    Seq Age Sex Outcome Treatment
    1