BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV 1150

    MDR report key: 2133276 · Received May 11, 2011

    Report

    Report Number
    2031702-2011-00100
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Report Date
    May 10, 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
    IL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS AT THE FIELD SERVICE CTR FOR A SCHEDULED PREVENTATIVE MAINTENANCE, A SOFTWARE UPGRADE, AND THE VENTILATOR ALARM WAS TOO QUIET AT 85DB. THE ALARM SOUNDER APPEARED TO HAVE BEEN PHYSICALLY DAMAGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA