BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNCS DC-I

    MDR report key: 6397774 · Received March 11, 2017

    Report

    Report Number
    2031172-2017-00312
    Event Type
    Malfunction
    Date Received
    March 11, 2017
    Date of Event
    February 16, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K051212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACURING NARRATIVE: ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE RETURNED SENSOR WAS EVALUATED. DURING EVALUATION THE SENSOR PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE SENSOR WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. IN ADDITION TO FUNCTIONAL TESTING, THE SENSOR WAS SUBJECTED TO SKIN SURFACE TEMPERATURE TESTING. NO ANOMALIES WERE DETECTED WHICH COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE., CORRECTED DATA: BRAND NAME WAS UPDATED FROM "LNCS ADTX" TO "LNCS DC-I". MODEL# WAS UPDATED FROM "1859" TO "21449." CATALOG# WAS UPDATED FROM "1859" TO "1863." LOT# WAS UPDATED FROM "0H052" TO "A10H052." DEVICE AVAILABLE FOR EVALUATION WAS UPDATED FROM A BLANK FIELD TO "LNC-10-GE." PMA/510K WAS UPDATED FROM "K101896" TO "K051212." DEVICE MANUFACTURE DATE WAS UPDATED FROM A BLANK FIELD TO "08/10/2010." LABELED FOR SINGLE USE WAS UPDATED FROM "YES" TO "NO."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PATIENT EXPERIENCED A BURN ON HIS FINGER AND THEY WOULD LIKE TO SEE IF THERE WAS ANY WAY TO TEST THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180316 LNCS DC-I OXIMETER DQA MASIMO - 40 PARKER 21449 A10H052

    Patients

    Seq Age Sex Outcome Treatment
    1 Other