BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5416342 · Received February 8, 2016

    Report

    Report Number
    2021710-2016-02970
    Event Type
    Malfunction
    Date Received
    February 8, 2016
    Date of Event
    August 27, 2013
    Report Date
    August 27, 2013
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE/COMPONENTS WERE NOT RETURNED FOR POSSIBLE FAILURE ANALYSIS EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE R1 IS NOT RESPONDING DURING AN ATTEMPT TO CALIBRATE THE DDI. CUSTOMER EXPLAINED THE OCCURED DURING PREVENTATIVE MAINTENANCE. A REPLACEMENT PWB ASSY DVR DISP INDICATOR WAS ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75198 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1