BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR PULSE OXIMETER

    MDR report key: 7035711 · Received November 15, 2017

    Report

    Report Number
    2936999-2017-05618
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    October 11, 2017
    Report Date
    November 15, 2017
    Manufacturer
    MEDIANA CO. LTD.
    Product Code
    DQA
    UDI-DI
    10884521182547
    PMA / PMN Number
    K141518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT DURING SETUP, SATSECONDS FEATURE WAS NOT ALARMING WHEN CIRCLE FILLED. IT HAD A DELAY OF APPROXIMATELY 30 SECONDS. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812005 NELLCOR PULSE OXIMETER OXIMETER DQA MEDIANA CO. LTD. PM1000N-RR 10884521182547

    Patients

    Seq Age Sex Outcome Treatment
    1