BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 7126624 · Received December 18, 2017

    Report

    Report Number
    2936999-2017-05693
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    December 1, 2017
    Report Date
    October 4, 2018
    Manufacturer
    MEDIANA CO. LTD.
    Product Code
    DQA
    PMA / PMN Number
    K021090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR ANALYSIS AND THE REPORTED ISSUE WAS CONFIRMED. A VISUAL INSPECTION WAS PERFORMED AND IT WAS OBSERVED THAT THE 44-PIN CABLE WAS NOT COMPLETELY SEATED FOUND THAT ONE OF THE CONNECTORS WAS BROKEN, ALLOWING IT TO SEPARATE AND NOT HOLD THE CABLE ON THE PINS PROPERLY. 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.

    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 STATING THAT A N560 PULSE OXIMETRY DISPLAY WAS MISSING SEGMENTS. ACCORDING TO THE REPORT THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905061 NELLCOR OXIMETER DQA MEDIANA CO. LTD. N560

    Patients

    Seq Age Sex Outcome Treatment
    1