BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 87505 · Received April 23, 1997

    Report

    Report Number
    1719232-1997-00004
    Event Type
    Malfunction
    Date Received
    April 23, 1997
    Date of Event
    March 19, 1997
    Report Date
    April 21, 1997
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    USER REPORTED THE HUMIDIFIER WAS NOT FILLING WITH WATER AND THERE WAS NO ALARM. USER RESPOND BY MANUALLY FILLING THE HUMIDIFIER AND THE DEVICE OPERATED NORMALLY. THERE WAS NO PATIENT INJURY.

    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