BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 4190001 · Received September 17, 2014

    Report

    Report Number
    2936999-2014-00835
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDIANA
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SERIAL NUMBER IS UNK; THEREFORE, THE MANUFACTURER DATE IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE UPPER PART OF THE SEGMENTS WERE SPORADICALLY MISSING, THEY DID NOT LIGHT. A TECHNICIAN AT THE HOSPITAL FOUND THE CABLE FROM THE DISPLAY PANEL WAS NOT LOCKED IN. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574061 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1