BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E500 GAS DELIVERY UNIT

    MDR report key: 3032688 · Received March 29, 2013

    Report

    Report Number
    2023050-2013-00249
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 11, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K061094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, NO PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DURING PATIENT USE, AN 'O2 SENSOR BA' ALARM OCCURRED. CALIBRATING THE O2 SENSOR COULD NOT SOLVE THE ISSUE. THIS ISSUE WAS RESOLVED BY REPLACING THE O2 SENSOR. NO PATIENT INJURY WAS REPORTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131382 E500 GAS DELIVERY UNIT CBK NEWPORT MEDICAL INSTRUMENTS E500

    Patients

    Seq Age Sex Outcome Treatment
    1