BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 72844 · Received February 22, 1997

    Report

    Report Number
    1719232-1997-00002
    Event Type
    Injury
    Date Received
    February 22, 1997
    Date of Event
    January 22, 1997
    Report Date
    February 21, 1997
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    USER REPORTED AN ALARM DURING DEVICE USE. ALARM (LOW TEMP) INDICATED A PROBABLE MALFUNCTION OF AN ACCESSORY (HUMIDIFIER CARTRIDGE) WHICH DOES NOT PREVENT DEVICE USE. USER RESPONDED BY USING A BACK-UP DEVICE THAT WAS AVAILABLE ON SITE. UPON INITIAL USE OF THE BACK-UP DEVICE, WITH THE SAME HUMIDIFIER CARTRIDGE, 8-10 CC OF WATER FROM THE HUMIDIFIER CARTRIDGE WAS DELIVERED TO THE PT. CLINICIANS RESPONDED WITH MANUAL VENTILATION AND SUCTIONING. PT WAS UNHARMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention