BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 7011154 · Received November 8, 2017

    Report

    Report Number
    2936999-2017-05611
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    October 9, 2017
    Report Date
    March 2, 2018
    Manufacturer
    MEDIANA CO. LTD.
    Product Code
    DQA
    PMA / PMN Number
    K021090
    Removal / Correction Number
    Z-2268-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR ANALYSIS AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. A VISUAL INSPECTION WAS PERFORMED AND IT WAS OBSERVED ALL THE COMPONENTS WERE ASSEMBLED ACCORDING TO MANUFACTURING PROCESS. A INFLATION/DEFLATION TEST WAS PERFORMED, AIR WAS APPLIED TO THE CUFF AND IT WAS OBSERVED THE CUFF HELD THE AIR AND NO DEFORMATIONS OR ANOMALIES WERE OBSERVED. INFORMATION HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED. CORRECTION: (FACILITY NAME, ADDRESS, PHONE #). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 A REPORT STATED THAT A N560 UNIT HAD MISSING SEGMENTS IN THE DISPLAY. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789162 NELLCOR OXIMETER DQA MEDIANA CO. LTD. N560

    Patients

    Seq Age Sex Outcome Treatment
    1