BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5499577 · Received March 14, 2016

    Report

    Report Number
    2021710-2016-03326
    Event Type
    Injury
    Date Received
    March 14, 2016
    Date of Event
    February 17, 2016
    Report Date
    February 17, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAREFUSION FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE TO EVALUATE THE SUSPECT DEVICE. THE CAREFUSION FSR CONFIRMED NO HARM DONE TO THE PATIENT. THE FSR RAN A PERFORMANCE TEST AND THE PROBLEM COULD NOT BE DUPLICATED. THE PATIENT CIRCUIT FROM THE INCIDENT COULD NOT BE FOUND. THE FSR RAN THE VENT FOR MORE THAN THIRTY (30) MINUTES AND THE MAP (MEAN AIRWAY PRESSURE) WAS VERY STABLE. THE FSR REPORTED THE VENT IS RUNNING TO MANUFACTURES SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE USING THE 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV), THE MAP (MEAN AIRWAY PRESSURE) WAS DRIFTING UP AND DOWN CAUSING THE MAX MAP (MAXIMUM MAP) TO EXCEED AND THE MIN MAP (MINIMUM MAP) EXCEED ALARMS TO ACTIVATE. THE ISSUE OCCURRED DURING PATIENT USE. THE PATIENT WAS PLACED ON ANOTHER HFOV. THERE IS NO REPORT OF PATIENT CONSEQUENCE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155213 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION, INC 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention