BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3971135 · Received April 29, 2014

    Report

    Report Number
    2936999-2014-00382
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 1, 2014
    Manufacturer
    PEDIANA
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPLAY PCB WAS CHANGED (B)(4). THE SERIAN NUMBER OF THE DISPLAY PCB PRECEDES A CORRECTIVE AND PREVENTIVE ACTION TAKEN BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE UNIT COULD NOT DISPLAY THE 7 SEGMENTS CLEARLY. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256196 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA PEDIANA N-550

    Patients

    Seq Age Sex Outcome Treatment
    1