BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VEMTO;ATPR

    MDR report key: 3060900 · Received April 10, 2013

    Report

    Report Number
    2023050-2013-00305
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 19, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, NO PT INFO WAS PROVIDED.

    Description of Event or Problem · 1

    DURING PT USE, A 'HIGH FIO2' ALARM OCCURRED. CALIBRATING THE O2 SENSOR COULD NOT SOLVE THE ISSUE. THIS ISSUE WAS RESOLVED BY REPLACING THE O2 SENSOR. NO PT INJURY WAS REPORTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150035 E360 VEMTO;ATPR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360

    Patients

    Seq Age Sex Outcome Treatment
    1