BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3832515 · Received March 17, 2014

    Report

    Report Number
    2936999-2014-00254
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    February 20, 2014
    Report Date
    March 13, 2014
    Manufacturer
    MEDIANA
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE COVIDIEN INVESTIGATION, THE FRONT PCB BOARD WAS IDENTIFIED AND REPLACED. MANUFACTURING DATE OF THIS UNIT PRECEDES A CORRECTIVE AND PREVENTATIVE ACTION TAKEN BY THE MANUFACTURER FOR THIS FAILURE MODE.

    Description of Event or Problem · 1

    AN N-560 WAS RETURNED TO THE COVIDIEN SERVICE CENTER FOR MEASUREMENT FAILURE, WHERE DURING A COVIDIEN INVESTIGATION ON (B)(4) 2014, THE DISPLAY SEGMENTS WERE FOUND TO BE NOT VISIBLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156964 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1