BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 5040387 · Received August 28, 2015

    Report

    Report Number
    2031702-2015-00195
    Event Type
    Injury
    Date Received
    August 28, 2015
    Date of Event
    February 22, 2015
    Report Date
    August 28, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE CUSTOMER'S BIOMEDICAL TECHNICIAN HAD EXAMED THE VENTILATOR AND FOUND THE VENTILATOR SMOLDERING INTERNALLY AT THE ELECTRICAL CORD. THE VENTILATOR'S PIGTAIL HAD BEEN REPLACED BY THE BIOMED TECH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT WAS PLACED ON THE VENTILATOR, THE RN WITNESSED THE VENTILATOR SPARKING AT THE ELECTRICAL OUTLET. THE RN CALLED FOR HELP AND BEGAN TO MANUALLY VENTILATE THE PATIENT. THE VENTILATOR SCREEN READ "LOW POWER". THE RESPIRATORY THERAPIST WAS CALLED, THE PATIENT WAS MOVED TO ANOTHER ROOM, AND THE PATIENT WAS PLACED ON A DIFFERENT VENTILATOR. THE VENTILATOR WAS PULLED AND ENGINEERING WAS CALLED. THERE WAS NO FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572436 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1200

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention