BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3060641 · Received March 28, 2013

    Report

    Report Number
    2031702-2013-00055
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 17, 2013
    Report Date
    June 25, 2013
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Additional Manufacturer Narrative · 1

    IT WAS IDENTIFIED BY THE FIELD SERVICE TECHNICIAN THAT THE EVENT DATE WAS (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR SHUT OFF AND TURNED BACK ON BY ITSELF WHILE IT WAS ON A PT. NO PT HARM REPORTED. IT IS UNK IF THE VENTILATOR HAD AN AUDIBLE ALARM WHEN THE REPORTED PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128932 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC. LTV 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI