BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RD SET GE - 12

    MDR report key: 12321082 · Received August 13, 2021

    Report

    Report Number
    3011353843-2021-00199
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    June 1, 2021
    Report Date
    July 23, 2021
    Product Code
    DQA
    PMA / PMN Number
    K050252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: THE RETURNED SENSOR WAS EVALUATED. DURING EVALUATION THE SENSOR PASSED ALL VISUAL AND FUNCTIONAL TESTING.  THE SENSOR WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. CORRECTED DATA: D1 BRAND NAME FROM "RD RAINBOW SET MD20-12" TO "RD SET GE - 12". D4: MODEL AND CATALOG FROM "4073" TO "4085". G5: 510(K) FROM "K042536" TO "K050252".

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE SPO2 MEASUREMENT INTERRUPTED, FAILED FOR UP TO 10 MINUTES. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SPO2 MEASUREMENT INTERRUPTED, FAILED FOR UP TO 10 MINUTES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215014 RD SET GE - 12 OXIMETER DQA 4085 20GAH

    Patients

    Seq Age Sex Outcome Treatment
    1