BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 226484 · Received May 26, 1999

    Report

    Report Number
    1719232-1999-00005
    Event Type
    Malfunction
    Date Received
    May 26, 1999
    Date of Event
    May 3, 1999
    Report Date
    May 25, 1999
    Manufacturer
    BUNNELL INC.
    Product Code
    LSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    USER REPORTED DEVICE ALARM (VENT FAULT 08) CONDITION WHICH PROMPTS USER TO RESET DEVICE. USER REPORTED THAT DEVICE COULD NOT BE RESET WITHOUT RECURRENCE OF ALARM CONDITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN