BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RD SET NEO CS-3

    MDR report key: 11252236 · Received January 29, 2021

    Report

    Report Number
    3011353843-2021-00016
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Date of Event
    November 28, 2020
    Report Date
    January 8, 2021
    Manufacturer
    MASIMO - 52 DISCOVERY
    Product Code
    DQA
    PMA / PMN Number
    K042536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, OTHER TEXT: THE DEVICE WAS EVALUATED. EXTERNAL VISUAL INSPECTION SHOWED SLIDING NECK TAPE AT THE SENSOR END CAUSING THE EMITTER ASSEMBLY TO DISLODGE FROM ITS WINDOW. THE SENSOR PASSED CONTINUITY TESTING, NO SHORT OR OPENS WERE DETECTED WHEN THE SENSOR IS MANIPULATED. FUNCTIONAL TESTING COULD NOT BE COMPLETED AS THE DISLODGED EMITTER ASSEMBLY PREVENTS THE SENSOR FROM ENGAGING IN MONITORING. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS: T6G 2B7, CORRECTED DATA: D1 BRAND NAME CORRECTED FROM LNCS TFA-1 TO RD SET NEO CS-3 D4 MODEL # CORRECTED FROM 3858 TO 4478. CATALOG # CORRECTED FROM 3858 TO 4478. LOT # UPDATED FROM A BLANK FIELD TO 20M53. UNIQUE IDENTIFIER (UDI) # UPDATED FROM A BLANK FIELD TO (B)(4). EXPIRATION DATE UPDATED FROM A BLANK FIELD TO 11/01/2023. G5 510(K) CORRECTED FROM K051439 TO K042536. H4 DEVICE MANUFACTURE DATE UPDATED FROM A BLANK FIELD TO 11/05/2020.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE PATIENT'S FINGER SPO2 PROBE WAS DISCREPANT (6-8 POINTS HIGHER) THAN ABG READINGS. AN ATTEMPT WAS MADE BY RN/RRT TO COMMENCE FOREHEAD PROVE MONITORING; THE PRODUCT WAS CONNECTED TO THE EXISTING MONITORING CABLE (CONNECTIONS FIT TOGETHER) BUT WE WERE UNABLE TO OBTAIN WAVEFORM OR RED LIGHT ON DEVICE TO ILLUMINATE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    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. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT'S FINGER SPO2 PROBE WAS DISCREPANT (6-8 POINTS HIGHER) THAN ABG READINGS. AN ATTEMPT WAS MADE BY RN/RRT TO COMMENCE FOREHEAD PROVE MONITORING; THE PRODUCT WAS CONNECTED TO THE EXISTING MONITORING CABLE (CONNECTIONS FIT TOGETHER) BUT WE WERE UNABLE TO OBTAIN WAVEFORM OR RED LIGHT ON DEVICE TO ILLUMINATE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149315 RD SET NEO CS-3 OXIMETER DQA MASIMO - 52 DISCOVERY 4478 20M53

    Patients

    Seq Age Sex Outcome Treatment
    1