BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 4953419 · Received July 30, 2015

    Report

    Report Number
    2936999-2015-00661
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    June 15, 2015
    Report Date
    July 1, 2015
    Manufacturer
    MEDIANA
    Product Code
    DQA
    PMA / PMN Number
    K021090
    Removal / Correction Number
    Z-2268-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ISSUE WAS CONFIRMED AS MISSING DIGITS ON THE DISPLAY. THE DISPLAY CARD AND BATTERY WERE REPLACED. PERFORMED FUNCTION CHECK AND COMPLIANCE TEST WERE THEN IN ACCORDANCE WITH THE MANUFACTURER'S DATA.

    Additional Manufacturer Narrative · 1

    THE REPORTED CUSTOMER COMPLAINT IS A KNOWN ISSUE AND HAS BEEN ISOLATED AND ACTION HAS BEEN TAKEN UNDER REMEDIAL ACTION EFFORTS. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS MISSING DIGITS ON THE DISPLAY. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498510 NELLCOR PULSE OXIMETER DQA MEDIANA N560

    Patients

    Seq Age Sex Outcome Treatment
    1