BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-LNCS DC-I

    MDR report key: 6117665 · Received November 21, 2016

    Report

    Report Number
    2031172-2016-01320
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    January 1, 1901
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K051212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED CABLE WAS EVALUATED. DURING INSPECTION, A MISSING LATCH AT THE M15 CONNECTOR, AND TORN BEND RELIEF AT SENSOR END WAS FOUND. DURING EVALUATION THE SENSOR PASSED ALL FUNCTIONAL TESTING. THE SENSOR WAS DETERMINED TO BE FUNCTIONING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: ADDITIONAL MANUFACTURING NARRATIVE (IF OTHER): (LOT #) WAS CORRECTED FROM 16C4W TO 13HBS. MFG DATE: WAS CORRECTED FROM 03/31/2016 TO 08/06/2013. BRAND NAME: WAS CORRECTED FROM RAINBOW RC-4 TO M-LNCS DC-I. (PMA/510K #): WAS CORRECTED FROM K080238 TO K051212. (MODEL #) WAS CORRECTED FROM 2406 TO 2501. (CATALOG #) WAS CORRECTED FROM 2406 TO 2501.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT READINGS AND NO READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769163 M-LNCS DC-I OXIMETER DQA MASIMO - 40 PARKER 2501 13HBS

    Patients

    Seq Age Sex Outcome Treatment
    1