BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2120346 · Received May 26, 2011

    Report

    Report Number
    2031702-2011-00107
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Report Date
    May 25, 2011
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE VENTILATOR ALARMED AUDIBLY/VISUALLY AT THE BEDSIDE, THE EXTERNAL NURSE CALL ALARM WAS NOT ACTIVE. THE VENTILATOR WAS CONNECTED TO THE PT 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 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI