BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 116089 · Received August 25, 1997

    Report

    Report Number
    1719232-1997-00009
    Event Type
    Malfunction
    Date Received
    August 25, 1997
    Date of Event
    July 3, 1997
    Report Date
    August 25, 1997
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING IN-HOUSE TESTING, A POWER SURGE CAUSED A FAILURE OF THE TRANISENT VOLTAGE SUPPRESSOR (TVS) WHICH PREVENTS FURTHER DEVICE USE. THERE WAS NO PT INVOLVED.

    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