BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RD SET NEO ADH SENSOR

    MDR report key: 6177146 · Received December 15, 2016

    Report

    Report Number
    2031172-2016-01431
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 18, 2016
    Manufacturer
    MASIMO - 52 DISCOVERY
    Product Code
    DQA
    UDI-DI
    10843997009598
    PMA / PMN Number
    K042536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE 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 INCLUDING SKIN SURFACE TEMPERATURE TEST. THE SENSOR WAS DETERMINED TO BE FUNCTIONING AS DESIGNED., CORRECTED DATA: CATALOG # CORRECTED FROM "4001" TO "4003" INITIAL REPORTER ALSO SENT REPORT TO FDA CORRECTED FROM "NO" TO "YES". LABELED FOR SINGLE USE CORRECTED FROM "NO" TO "YES".

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BLISTER WAS IDENTIFIED ON THE PATIENT'S RIGHT FOOT DURING SITE CHANGE AT MIDNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828055 RD SET NEO ADH SENSOR OXIMETER DQA MASIMO - 52 DISCOVERY 4003 16J9S 10843997009598

    Patients

    Seq Age Sex Outcome Treatment
    1 275 DA Other RD RNBOW SET CABLE