BEUDAMED
    FDA Adverse Event Summary report: N

    LIFE PULSE HFV

    MDR report key: 2912998 · Received January 8, 2013

    Report

    Report Number
    2912998
    Date Received
    January 8, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 7, 2013
    Manufacturer
    BUNNELL INC.
    Product Code
    LSZ
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ON HIGH FREQUENCY JET VENTILATOR. CIRCUIT FAULT ALARMED. PATIENT WAS HAND VENTILATED AND CIRCUIT CHANGED. PATIENT TOLERATED WELL. NO SEQUELAE.HOSPITAL RECEIVED VOLUNTARY RECALL NOTICE ON CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10053 LIFE PULSE HFV VENTILATOR, HIGH FREQUENCY, PATIENT CIRCUIT LSZ BUNNELL INC. * 12J448

    Patients

    Seq Age Sex Outcome Treatment
    1 52 DA