BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E360 VENTILATOR

    MDR report key: 4092333 · Received August 19, 2014

    Report

    Report Number
    2023050-2014-00360
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    August 2, 2014
    Report Date
    August 5, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING THE EVALUATION AND REPAIR OF THE VENTILATOR. COVIDIEN REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT, THE E360 VENTILATOR SCREEN BECAME BLANK, AND GENERATED AN ALARM. ADDITIONALLY, WHEN AN EXTERNAL MONITOR WAS CONNECTED, A "NO SIGNAL" ERROR WAS DISPLAYED. ALTHOUGH THE VENTILATOR DID NOT STOP CYCLING, THE PATIENT WAS TRANSFERRED TO ANOTHER UNIT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500270 E360 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention