BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 96405 · Received May 28, 1997

    Report

    Report Number
    1719232-1997-00005
    Event Type
    Malfunction
    Date Received
    May 28, 1997
    Date of Event
    May 8, 1997
    Report Date
    May 27, 1997
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    USER REPORTED THAT A POWER VARIANCE SHUT THE VENTILATOR DOWN. IT WOULD NOT RESTART. PT WAS SUPPORTED WITH CONVENTIONAL VENTILATION UNTIL A BACK-UP DEVICE WAS AVAILABLE. PT WAS NOT INJURED.

    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 5 MO