BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N85 CAPNO/OXIMETER

    MDR report key: 3850849 · Received February 11, 2014

    Report

    Report Number
    8044004-2014-00002
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    December 31, 2013
    Report Date
    January 13, 2014
    Manufacturer
    ORIDION -RX
    Product Code
    CCK
    PMA / PMN Number
    K024300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION DID NOT CONFIRM NO ALARM. ALL ALARMS AND READINGS DISPLAYED PROPERLY AND PASSED ALL TESTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONITOR WAS NOT ALARMING. THE CUSTOMER DID NOT STATE IF THE MALFUNCTION OCCURRED DURING PATIENT USE AND THAT THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90501 OXIMAX N85 CAPNO/OXIMETER CCK, DQA CCK ORIDION -RX N-85

    Patients

    Seq Age Sex Outcome Treatment
    1