BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 4222200 · Received November 3, 2014

    Report

    Report Number
    2936999-2014-00959
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDIANA
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT RETURNED TO COVIDIEN FOR EVALUATION. CUSTOMER REQUESTED THE PART NUMBER FOR THE FRONT PCB BOARD. THE SERIAL NUMBER PRECEDES A CORRECTIVE ACTION PERFORMED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT OF A N560 WITH ONE SEGMENT THAT IS GOING IN AND OUT ON THE SPO2 PORTION OF THE DISPLAY. CUSTOMER STATED THAT THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703059 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1