BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3880249 · Received April 8, 2014

    Report

    Report Number
    2936999-2014-00295
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 10, 2014
    Manufacturer
    MEDIANA
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CIRCUIT THAT DISPLAYS THE SEGMENTS HAD A CONNECTION FAILURE. THE FRONT BOARD WAS REPLACED AND THE PROBLEM RESOLVED. (B)(4). THE SERIAL NUMBER OF THE DISPLAY PCB PRECEDES A CORRECTIVE AND PREVENTIVE ACTION TAKEN BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT PART OF THE HEART RATE READING WAS LACKING. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211797 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1