BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 7144246 · Received December 22, 2017

    Report

    Report Number
    2936999-2017-05706
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Report Date
    December 22, 2017
    Manufacturer
    MEDIANA CO. LTD.
    Product Code
    DQA
    PMA / PMN Number
    K021090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT CUSTOMER ALLEGED THAT OXIMAX PULSE OX WAS GIVING 5% HIGH READING WITH TEST SIMULATOR. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922156 NELLCOR OXIMETER DQA MEDIANA CO. LTD. N560

    Patients

    Seq Age Sex Outcome Treatment
    1