BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3826524 · Received February 28, 2014

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    Report

    Report Number
    2936999-2014-00195
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 5, 2014
    Manufacturer
    MEDIANA
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT RETURNED TO COVIDIEN. A SIMILAR INVESTIGATION HAS BEEN PERFORMED IN 2936999-2013-00113, (B)(4). SERIAL NUMBER PRECEDES A PREVENTIVE ACTION TAKEN BY THE MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PULSE WASN'T PROPERLY DISPLAYED WITH SEGMENTS NOT LIT. DISTRIBUTOR CONFIRMED THE FAILURE AND REPLACED THE FRONT PCB BOARD. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124125 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1