BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360

    MDR report key: 2852487 · Received November 15, 2012

    Report

    Report Number
    2023050-2012-00275
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 25, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENT
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PATIENT USE, A 'O2 SENSOR ERROR' ALARM OCCURRED. CALIBRATING THE O2 SENSOR COULD NOT SOLVE THE ISSUE. THIS ISSUE WAS RESOLVED BY REPLACING THE O2 SENSOR. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E360 CBK NEWPORT MEDICAL INSTRUMENT E360

    Patients

    Seq Age Sex Outcome Treatment
    1