BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 3240838 · Received July 17, 2013

    Report

    Report Number
    2936999-2013-00509
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SANMINA - SCI SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT WAS VERIFIED. THE UI PCB WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE DISPLAY WAS MISSING SEGMENTS. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332675 NELLCOR OXIMAX N-65 PULSE OXIMETER DQA SANMINA - SCI SYSTEMS N-65

    Patients

    Seq Age Sex Outcome Treatment
    1