BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 4092617 · Received August 19, 2014

    Report

    Report Number
    2936999-2014-00767
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    SANMINA-SCI SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    COULD NOT VERIFY THE CUSTOMER'S REPORT OF LOW READINGS. AFTER THREE DAYS OF TESTING, THE READING DID NOT VERY MORE THAN 1 UNIT OF MEASURE. UNIT PASSES ALL TESTS AND HAS ALL UPGRADES. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION THAT THIS N65 PULSE OXIMETER IS GIVING LOW READINGS (OXIMETRY). THE READINGS WERE IN THE 70'S AND WHEN THE PATIENT WAS PLACED ON A DIFFERENT MONITOR, THE READINGS WERE IN THE 90'S. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496935 NELLCOR OXIMAX N-65 PULSE OXIMETER DQA SANMINA-SCI SYSTEMS N-65

    Patients

    Seq Age Sex Outcome Treatment
    1