BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 6977595 · Received October 25, 2017

    Report

    Report Number
    2936999-2017-05574
    Event Type
    Malfunction
    Date Received
    October 25, 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR ANALYSIS AND THE REPORTED ISSUE WAS CONFIRMED. A VISUAL INSPECTION WAS PERFORMED AND IT WAS OBSERVED THAT UNIT WAS MISSING DISPLAY SEGMENTS. THE INVESTIGATION COULD NOT DETERMINE THE ROOT CAUSE OF THE EVENT. NO TREND HAS BEEN IDENTIFIED FOR THIS ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT STATING A N560 PULSE OXIMETRY UNIT DISPLAY WAS MISSING SEGMENTS. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756648 NELLCOR OXIMETER DQA MEDIANA CO. LTD. N560

    Patients

    Seq Age Sex Outcome Treatment
    1