BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3831811 · Received March 5, 2014

    Report

    Report Number
    2936999-2014-00160
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 5, 2014
    Manufacturer
    MEDIANA
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AT THE COVIDIEN (B)(4) SERVICE CENTER WHERE THE REPORTED CONDITION WAS VERIFIED. INVESTIGATION ISOLATED THE FAILURE OF MISSING SEGMENTS TO THE FRONT PCB BOARD. SERIAL NUMBER OF THE FRONT PCB BOARD PRECEDES A CORRECTIVE AND PREVENTIVE ACTION TAKEN BY THE MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT DURING USE, A MISSING SEGMENT OF SPO2 READING WAS FOUND. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132341 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1