BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 2142825 · Received June 21, 2011

    Report

    Report Number
    2031702-2011-00133
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 22, 2011
    Report Date
    June 21, 2011
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR DID NOT ALARM WHEN THE PT CIRCUIT TUBING WAS DISCONNECTED FROM THE SIDE OF VENTILATOR. THE PARAMEDICS WERE CALLED AND HELPED MANUALLY VENTILATE/STABILIZE THE PT UNTIL A REPLACEMENT VENTILATOR ARRIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention