BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2111344 · Received May 18, 2011

    Report

    Report Number
    2031702-2011-00104
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Report Date
    May 16, 2011
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE VENTILATOR WAS ORIGINALLY RETURNED TO THE FIELD SERVICE CTR FOR A SCHEDULED PREVENTATIVE MAINTENANCE. IT WAS REPORTED THAT WHEN THE FIELD SERVICE TECH WAS CHECKING THE NURSE CALL JACK, NO CHANGE IS DETECTED IN RESISTANCE (OF CABLE) WHEN SWITCHING FROM A NO ALARM SITUATION TO AN ALARM SITUATION. THE VENTILATOR ALARMED AS APPROPRIATE. THE VENTILATOR WAS NOT CONNECTED TO A PT WHEN THE REPORTED PROBLEM OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA