BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3942110 · Received March 4, 2014

    Report

    Report Number
    2936999-2014-00209
    Event Type
    Malfunction
    Date Received
    March 4, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 3, 2014
    Manufacturer
    MEDIANA
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS ISOLATED TO THE DISPLAY. VISUAL INSPECTION SHOWED COLD SOLDER ON THE DISPLAY PCB. THE DISPLAY PCB WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE SPO2 LIGHTS ON THE DISPLAY WERE GOING OUT. UPON EVALUATION IT WAS DISCOVERED THAT ALL THE DIGITS ON THE SPO2 SIDE OF THE DISPLAY WERE MISSING A SEGMENT. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129630 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1