BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 4092734 · Received August 20, 2014

    Report

    Report Number
    2936999-2014-00742
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 29, 2014
    Manufacturer
    MEDIANA
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN SERVICE TECH VERIFIED THE TOP LINE OF DISPLAY SEGMENTS WERE INTERMITTENTLY MISSING, AND REPLACED THE FRONT PCB BOARD. THE MANUFACTURER DATE OF THE DEVICE PRECEDES A CORRECTIVE ACTION TAKEN BY THE MANUFACTURER.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT OF A N560 THAT DID NOT DISPLAY THE TOP LINE OF THE SEGMENTS. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500572 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1