BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIGH-FREQUENCY VENTILATOR

    MDR report key: 2766605 · Received September 26, 2012

    Report

    Report Number
    MW5027076
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 21, 2012
    Manufacturer
    BUNNELL INC
    Product Code
    LSZ
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    BUNNELL LIFE PULSE HIGH-FREQUENCY VENTILATOR HEATED WIRE. BREATHING CIRCUIT OVERHEATED, SINGLE PT USE. BREATHING CIRCUIT EMITTED SMOKE AND SECTIONS OF THE CIRCUIT MELTED. NO PT SAFETY COMPROMISED, NOTIFIED VENDOR AND ECRI. REMOVED ALL DEVICE OUT OF SERVICE DUE TO NATURE LIFE SUPPORT DEVICE, 3 INCIDENTS IN 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH-FREQUENCY VENTILATOR HIGH-FREQUENCY VENTILATOR LSZ BUNNELL INC 203
    2 HIGH-FREQUENCY VENTILATOR HIGH-FREQUENCY VENTILATOR LSZ BUNNELL INC 203
    3 HIGH-FREQUENCY VENTILATOR HIGH-FREQUENCY VENTILATOR LSZ BUNNELL INC 203

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening