BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2923034 · Received December 27, 2012

    Report

    Report Number
    2031702-2012-00327
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Report Date
    December 27, 2012
    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
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR SHUT DOWN WHILE ON A PT. THE VENTILATOR WOULD NOT POWER BACK ON. IT IS UNK IF THE VENTILATOR ALARMED WHEN THE REPORTED PROBLEM OCCURRED. NO PT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI