BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65P

    MDR report key: 2872015 · Received December 11, 2012

    Report

    Report Number
    2936999-2012-00636
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 13, 2012
    Manufacturer
    SANMINA-SCI SYSTEM
    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 FAILURE WAS ISOLATED TO THE UI BOARD. THE UI BOARD WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012, THAT THE DISPLAY WAS DEFECTIVE. COVIDIEN DETERMINED ON (B)(4) 2012 THAT THERE WAS A DISPLAY FAILURE FOR MISSING SEGMENTS. THERE WAS NO PATIENT INVOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1