BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5416343 · Received February 8, 2016

    Report

    Report Number
    2021710-2016-02976
    Event Type
    Malfunction
    Date Received
    February 8, 2016
    Date of Event
    September 9, 2013
    Report Date
    September 9, 2013
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL REPORT WAS IDENTIFIED AS A LATE SUBMISSION DURING A TWO YEAR RETROSPECTIVE REVIEW OF COMPLAINTS AND MDR¿S FOLLOWING RECEIPT OF AN UNTITLED LETTER ISSUED BY THE FDA. (B)(4) A CAREFUSION FIELD SERVICE REPRESENTATIVE VISITED THE USER FACILITY TO EVALUATE THE DEVICE. DURING THE COURSE OF THE EVALUATION THE FIELD SERVICE REPRESENTATIVE: ONSITE (B)(6) 2013 COMPLAINT IS INSP TIME CONTROL/DISPLAY IS ERRATIC. VERIFIED COMPLAINT - FOUND WIRES LOOSE AT MOLEX CONNECTOR FOR IT METER. INSTALLED AND CRIMPED 2 NEW PINS. PERFORMED CIRCUIT CALIBRATION AND PERFORMANCE CHECKOUT, PAW=20, DELTAP=61 W/O HUMIDIFIER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INSP TIME (IT) KNOB IS NOT RESPONDING QUICKLY ENOUGH WHEN THEY TRY TO ADJUST IT. CUSTOMER UNABLE TO CONFIRM IF IT WAS IN SPEC. PATIENT INVOLVEMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75152 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1