BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 148551 · Received February 7, 1998

    Report

    Report Number
    1719232-1998-00001
    Event Type
    Malfunction
    Date Received
    February 7, 1998
    Date of Event
    January 7, 1998
    Report Date
    February 6, 1998
    Manufacturer
    BUNNELL INC
    Product Code
    LSZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FILING OF THIS REPORT DOES NOT REFLECT A CONCLUSION BY BUNNELL INCORPORATED THAT THE DEVICE IS DEFECTIVE, NOR DOES IT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. EVALUATION SUMMARY: CONTINUED FAILURE INVESTIGATION FOUND INTERMITTENT FAILURE DUE TO FAILURE OF +12 VOLT VOLTAGE REGULATOR.

    Description of Event or Problem · 1

    USER REPORTED AN ALARM CONDITION (VENT FAULT) DURING SET-UP PROCEDURE. ALARM COULD NOT CLEARED. USER USED BACK-UP DEVICE FOR THERAPY. NO PT INJURY. PT WEIGHT: 0.33 KGS.

    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 17 DAY