BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RD RAINBOW SET-2 INF

    MDR report key: 11016324 · Received December 16, 2020

    Report

    Report Number
    3011353843-2020-00203
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    January 14, 2020
    Report Date
    November 19, 2020
    Manufacturer
    MASIMO - 52 DISCOVERY
    Product Code
    DQA
    PMA / PMN Number
    K140188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 SPHB BIAS ON SENSORS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483745 RD RAINBOW SET-2 INF OXIMETER DQA MASIMO - 52 DISCOVERY 4028

    Patients

    Seq Age Sex Outcome Treatment
    1