BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 46727 · Received September 5, 1996

    Report

    Report Number
    1719232-1996-00008
    Event Type
    Malfunction
    Date Received
    September 5, 1996
    Date of Event
    August 4, 1996
    Report Date
    September 5, 1996
    Manufacturer
    BUNNELL INCORPORATED
    Product Code
    LSZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    USER REPORTED AN ALARM DURING SELF TEST PROCEDURE DURING SET-UP FOR A PT. ALARM (VENT FAULT 03) INDICATED A DEVICE MALFUNCTION PREVENTING DEVICE USE. THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN