BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 7139406 · Received December 21, 2017

    Report

    Report Number
    2936999-2017-05702
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 16, 2017
    Report Date
    December 21, 2017
    Manufacturer
    MEDIANA CO. LTD
    Product Code
    DQA
    PMA / PMN Number
    K142865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THE UNIT GENERATED HIGH SPO2 READINGS ALTHOUGH PATIENT'S VITAL WAS STABLE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918060 NELLCOR OXIMETER DQA MEDIANA CO. LTD 10005941JP

    Patients

    Seq Age Sex Outcome Treatment
    1