BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 175318 · Received July 2, 1998

    Report

    Report Number
    1719232-1998-00010
    Event Type
    Death
    Date Received
    July 2, 1998
    Date of Event
    June 9, 1998
    Report Date
    June 30, 1998
    Manufacturer
    BUNNELL INC.
    Product Code
    LSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    USER REPORTED A POWER SHUT-DOWN THAT CAUSED A DEVICE ALARM (VENT FAULT 05). DEVICE ALARM PROMPTS USER TO CONDUCT POWER RESET ON THE DEVICE AND SUPPORT THE PT WITH ALTERNATIVE MEANS UNTIL RESET HAS OCCURRED. DEVICE RESET WAS SUCCESSFUL, HOWEVER, WHILE SUPPORTING THE BABY VIA MANUAL HAND-BAGGING, THE PT WAS EXTUBATED AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PULSE HIGH FREQUENCY VENTILATOR VENTILATOR LSZ BUNNELL INC. 203 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death