BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMTER

    MDR report key: 2860177 · Received November 21, 2012

    Report

    Report Number
    2936999-2012-00611
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 24, 2012
    Manufacturer
    COVIDIEN
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ISOLATED THE FAILURE TO THE SPEAKER. A REPLACEMENT SPEAKER WAS PROVIDED AND PER THE CUSTOMER, THE ISSUE WAS RESOLVED. THIS PRODUCT IS NO LONGER MANUFACTURED.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT THAT DURING POST (POWER-ON-SELF-TEST) IS WAS OBSERVED THAT THERE WAS NO ALARM. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXIMAX N-595 PULSE OXIMTER PULSE OXIMETER DQA COVIDIEN N595

    Patients

    Seq Age Sex Outcome Treatment
    1