BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 7139374 · Received December 21, 2017

    Report

    Report Number
    2936999-2017-05701
    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

    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 THE UNIT GENERATED HIGH SPO2 READINGS ALTHOUGH PATIENT'S VITAL WAS STABLE. THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917160 NELLCOR OXIMETER DQA MEDIANA CO. LTD 10005941JP

    Patients

    Seq Age Sex Outcome Treatment
    1