BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-LNCS DC-I

    MDR report key: 6117527 · Received November 21, 2016

    Report

    Report Number
    2031172-2016-01324
    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 EVALUATION THE CABLE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE CABLE WAS DETERMINED TO BE FUNCTIONING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: ADDITIONAL MANUFACTURING NARRATIVE (IF OTHER): (LOT #) WAS CORRECTED FROM 15HJF TO 15HJQ. MFG DATE: WAS CORRECTED FROM 08/11/2015 TO 08/21/2015. 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
    767427 M-LNCS DC-I OXIMETER DQA MASIMO - 40 PARKER 2501 15HJQ

    Patients

    Seq Age Sex Outcome Treatment
    1