BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 3820043 · Received April 28, 2014

    Report

    Report Number
    3820043
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    January 3, 2014
    Report Date
    April 28, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US

    Narratives

    Description of Event or Problem · 1

    TWO SENSORMEDICS HIGH FREQUENCY VENTILATORS (MODELS 3100A AND 3100B) HAVE FAILED IN USE IN RECENT MONTHS. THE INVESTIGATION FOUND WATER INGRESS INTO THE PROXIMAL AIRWAY LINE WHICH CAUSED THE PRESSURE SENSORS TO FAIL. I HAVE COMMENTS FROM THE MANUFACTURER THAT CONTRADICT EACH OTHER AND PICTURES OF THE INTERNAL CIRCUIT OF THE MACHINE IF REQUIRED. MANUFACTURER'S RESPONSE: TECHNICAL SUPPORT #1: "WATER INGRESS FREQUENTLY OCCURS ON THE 3100B BECAUSE IT USES A SHORTER CIRCUIT...DEPENDENT ON PATIENT Y POSITION." TECHNICAL SUPPORT #2 (FROM MANUAL): "A TRICKLE FLOW OF DRY GAS FROM THE BLENDER FLOWS CONSTANTLY FROM THE 3100B TO THE PATIENT Y TO KEEP WATER VAPOR FROM EVEN PARTIALLY OBSTRUCTING THIS PRESSURE SENSING PATHWAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254538 SENSORMEDICS VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A *
    254539 SENSORMEDICS VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100B *

    Patients

    Seq Age Sex Outcome Treatment
    1 *