BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3063836 · Received April 3, 2013

    Report

    Report Number
    2031702-2013-00071
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT NURSE CALL ALARM WAS NOT FUNCTIONING. THIS WAS FOUND DURING TESTING AND WAS NOT CONNECTED TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135427 LTV VENTILATOR, CONTINUOUS /CBK CBK CAREFUSION 203, INC LTV 900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA