BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 110707 · Received July 31, 1997

    Report

    Report Number
    1719232-1997-00007
    Event Type
    Malfunction
    Date Received
    July 31, 1997
    Date of Event
    July 1, 1997
    Report Date
    July 30, 1997
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    USER REPORTED LACK OF CONTACT IN HUMIDIFIER HEATER, WHICH PREVENTS HEATING OF WATER. THERE WAS NO PT INVOLVED. PROBLEM DISCOVERED OUTSIDE OF DEVICE USE.

    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 NA