BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 296741 · Received September 13, 2000

    Report

    Report Number
    1719232-2000-00006
    Event Type
    Malfunction
    Date Received
    September 13, 2000
    Date of Event
    August 14, 2000
    Report Date
    September 11, 2000
    Manufacturer
    BUNNELL INCORPORATED
    Product Code
    LSZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE MALFUNCTION DURING SET UP FOR PT USE. ALARM CONDITION (VENT FAULT 03). NO HARM OR INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PULSE HIGH FREQUENCY VENTILATOR VENTILATOR LSZ BUNNELL INCORPORATED 203 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN