BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 3770241 · Received March 10, 2014

    Report

    Report Number
    2936999-2014-00114
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 10, 2014
    Manufacturer
    SANMINA-SCI SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT RE-SEATING THE INTERNAL CONNECTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE N65P MONITOR DISPLAYS IS MISSING SEGMENTS. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143838 NELLCOR OXIMAX N-65 PULSE OXIMETER DQA SANMINA-SCI SYSTEMS N-65

    Patients

    Seq Age Sex Outcome Treatment
    1