BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RD RAINBOW LITE SET-1 NEO ADH

    MDR report key: 23230359 · Received October 6, 2025

    Report

    Report Number
    3019388613-2025-00118
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 1, 2025
    Report Date
    September 7, 2025
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    QWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: MASIMO HAS REACHED OUT TO THE CUSTOMER TO REQUEST THE RETURN OF THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE DEVICE IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. HEALTH EFFECT IMPACT CODE: NOT ENOUGH INFORMATION PROVIDED TO DETERMINE PATIENT IMPACT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A CONCERN OF SLOW RESPONSE IN READING OF SPO2 AND PULSE RATE PARAMETERS. "THIS ISSUE CONTINUES TO PERSIST. YESTERDAY, WE EXPERIENCED AN EMERGENCY CASE WHERE A BABY WAS BORN, AND THE MACHINE FAILED TO PICK UP THE FHR AND SPO2. IT TOOK NEARLY SEVEN MINUTES BEFORE ANY DATA APPEARED, AND EVEN THEN, THE READINGS DID NOT ACCURATELY REFLECT THE BABY'S CONDITION. GIVEN THE SERIOUSNESS OF SUCH DELAYS DURING NEONATAL RESUSCITATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2747216 RD RAINBOW LITE SET-1 NEO ADH HYPEROXIA MONITORING DEVICE ADJUNCT TO PULSE OXIMETRY QWE MASIMO - 15750 ALTON PKWY 4045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown