BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 235417 · Received August 13, 1999

    Report

    Report Number
    1719232-1999-00009
    Event Type
    Injury
    Date Received
    August 13, 1999
    Date of Event
    July 15, 1999
    Report Date
    August 12, 1999
    Manufacturer
    BUNNELL INC.
    Product Code
    LSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    USER WAS ALERTED BY ALARMS TO A HIGH PRESSURE DELIVERY TO PT. EVENT OCCURRED FOLLOWING OPERATIONAL VERIFICATION OF THE DEVICE. PT PRESENTED WITH BILATERAL PNEUMOTHORACES FROM EVENT, WHICH REQUIRED MEDICAL RESPONSE.

    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 1 DAY Required Intervention