BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2820476 · Received October 4, 2012

    Report

    Report Number
    2031702-2012-00247
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    August 29, 2012
    Report Date
    October 4, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS TURNING OFF FOR A COUPLE OF MINUTES AND THEN TURNING BACK ON WITH AN AUDIBLE (RESET) ALARM WHILE CONNECTED TO A PT. THAT EVENT REPEATED FOR AN HOUR. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC. LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR