BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 25092263 · Received May 6, 2026

    Report

    Report Number
    MW5187691
    Event Type
    Death
    Date Received
    May 6, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 1, 2026
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 6/15/026 FOR MW5187691 TO UPDATE TO NON-DEATH STATUS/NON-CODE BLUE STATUS. I AM WRITING TO REQUEST A CORRECTION TO THE MEDWATCH FORM 3500 THAT I SUBMITTED ON MAY 1, 2026. IN SECTION B (ADVERSE EVENT, PRODUCT PROBLEM), ITEM B2, I INADVERTENTLY SELECTED "DEATH." THIS SELECTION WAS MADE IN ERROR. THE PRODUCT DID NOT CONTRIBUTE TO THE PATIENT'S DEATH, AND THE "DEATH" DESIGNATION DOES NOT ACCURATELY REFLECT THE CIRCUMSTANCES OF THIS REPORT. BASED ON MY REVIEW, NONE OF THE AVAILABLE OUTCOME SELECTIONS IN THIS SECTION APPLY TO THIS INCIDENT.

    Description of Event or Problem · 0

    PATIENT WAS ON A JET VENTILATOR WITH AN LOW PRESSURE ALARM BEGAN TO SOUND, STAFF ATTEMPTED TO TROUBLESHOOT PROBLEM. UNSUCCESSFUL ATTEMPTS AT TROUBLESHOOTING VENTILATOR, 24 HOUR MANUFACTURER HOTLINE CALLED FOR TECH SUPPORT, LOW PRESSURE ALARM PERSISTED. PATIENT SWITCHED TO A DIFFERENT VENTILATOR, UPON REVIEWING JET VENTILATOR, IT WAS NOTED THAT CASSETTE TUBING WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178550 LIFE PULSE HIGH FREQUENCY VENTILATOR VENTILATOR, HIGH FREQUENCY LSZ BUNNELL, INC. 204

    Patients

    Seq Age Sex Outcome Treatment
    1