BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3866636 · Received April 25, 2014

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    Report

    Report Number
    2936999-2014-00358
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MEDIANA
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN ENGINEER VERIFIED THE COMPLAINT THAT THE DISPLAY WAS MISSING SEGMENTS. ROOT CAUSE DETERMINED TO BE CRACKED AND COLD SOLDER ON THE 7-SEGMENT DISPLAY POSTS. THE DISPLAY PCB WAS REPLACED. (B)(4). THE SERIAL NUMBER OF THE DISPLAY PCB PRECEDES A CORRECTIVE AND PREVENTIVE ACTION TAKEN BY THE MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE MONITOR IS MISSING SEGMENTS IN THE DISPLAY. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250483 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1