BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 3960782 · Received June 26, 2014

    Report

    Report Number
    2936999-2014-00562
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 3, 2014
    Manufacturer
    COVIDIEN
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN BY THE BIOMEDICAL ENGINEER THAT THIS N-595 HAS NO AUDIO. THE FACILITY BIOMED ENGINEER ISOLATED THE ISSUE TO THE MAIN PCB BOARD. THERE WAS NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373164 OXIMAX N-595 PULSE OXIMETER PULSE OXIMETER DPZ COVIDIEN N-595

    Patients

    Seq Age Sex Outcome Treatment
    1