BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-G

    MDR report key: 23273667 · Received October 12, 2025

    Report

    Report Number
    3019388613-2025-00121
    Event Type
    Malfunction
    Date Received
    October 12, 2025
    Date of Event
    January 1, 2025
    Report Date
    September 15, 2025
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    DQA
    UDI-DI
    00843997000666
    PMA / PMN Number
    K213676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: THE RETURNED RAD-G WAS EVALUATED. A DAMAGED POWER BUTTON WAS FOUND DURING VISUAL INSPECTION OF THE DEVICE. THE DAMAGED POWER BUTTON MADE IT DIFFICULT TO POWER ON THE DEVICE. ADDITIONALLY, THE DEVICE REMAINED POWERED ON DURING TESTING AND THE POWER ISSUE WAS NOT OBSERVED. HOWEVER, THE DEVICE WAS RETURNED WITH SPOT CHECK MODE ENABLED. IN THIS MODE, THE DEVICE IS DESIGNED TO AUTOMATICALLY POWER OFF AFTER A MINUTE OF INACTIVITY.

    Additional Manufacturer Narrative · 0

    OTHER TEXT: THE DEVICE HAS NOT BEEN RETURNED TO THE INVESTIGATION FACILITY TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE DEVICE IS RECEIVED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. HEALTH EFFECT IMPACT CODE: NO ADVERSE EVENT, NO PATIENT IMPACT H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE RAD-G "ON/OFF SWITCH STICKS" AND THE "DEVICE SWITCHES OFF SUDDENLY." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE RAD-G "ON/OFF SWITCH STICKS" AND THE "DEVICE SWITCHES OFF SUDDENLY." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2614370 RAD-G OXIMETER DQA MASIMO - 15750 ALTON PKWY 9849 00843997000666

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown