BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 121393 · Received September 19, 1997

    Report

    Report Number
    1719232-1997-00010
    Event Type
    Injury
    Date Received
    September 19, 1997
    Date of Event
    August 28, 1997
    Report Date
    September 19, 1997
    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 REPORTED AN ALARM CONDITION THAT PROMPTED CORRECTION. USER ELECTED TO CHANGE DEVICES. PT EXPERIENCED BRADYCARDIA AND DE-SATURATION DURING THE EVENT. PT'S CONDITION IMPROVED FOLLOWING THE EVENT.

    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 11 DAY Required Intervention