BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3888552 · Received April 30, 2014

    Report

    Report Number
    2936999-2014-00360
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MEDIANA
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE UNIT PASSED ALL FUNCTIONAL TESTS WITHOUT AN INTERMITTENT FAILURE; HOWEVER, UPON VISUAL INSPECTION SOLDER DEFECTS WERE IDENTIFIED ON THE FRONT PCB AND MAIN PCB BOARDS. THESE BOARDS WERE REPLACED.

    Description of Event or Problem · 1

    RECEIVED A REPORT THAT THE N-560 IS INTERMITTENTLY MISSING SEGMENTS ON THE SATURATION PORTION OF THE DISPLAY. THE FAILURE HAPPENED DURING PREVENTIVE MAINTENANCE WHEN THE DEVICE WAS NOT BEING USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258530 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1