BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RD SET

    MDR report key: 23936830 · Received December 31, 2025

    Report

    Report Number
    3019388613-2025-00189
    Event Type
    Malfunction
    Date Received
    December 31, 2025
    Date of Event
    December 5, 2025
    Report Date
    December 5, 2025
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    DQA
    UDI-DI
    00843997014298
    PMA / PMN Number
    K180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: THE FOLLOW-UP MDR WAS FILED TO MAKE CORRECTIONS TO THE FOLLOWING FIELDS IN SECTION D. SUSPECT MEDICAL DEVICE, G. ALL MANUFACTURERS, AND H. DEVICE MANUFACTURERS ONLY: D1. BRAND NAME WAS LNCS-II RAINBOW; IS RD SET, D4. MODEL # WAS 4067; IS 4052, D4. LOT # WAS BLANK; IS 22M5H, D4. UNIQUE DEVICE IDENTIFIER (UDI) # WAS (B)(4). G4. PMA/510(K) # WAS K080238; IS K180046. H4. DEVICE MANUFACTURE DATE WAS BLANK; IS 11/24/2022. H3 OTHER TEXT: SENSOR NOT RETURNED.

    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 PRODUCT 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 : SENSOR NOT RETURNED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED "THE SENSOR STOPPED WORKING WHEN THE PATIENT WAS CONNECTED, BUT THERE WAS NO BREAKAGE ON THE DEVICE. THIS TYPE OF SENSOR HAS A HIGHER IMPEDANCE, RESULTING IN A SATURATION READING APPROXIMATELY 8-10 POINTS LOWER THAN ARTERIAL BLOOD GAS ANALYSIS. THIS HAS BEEN REPORTED SEVERAL TIMES BY MY TEAM. THE PERFUSION SIGNAL IS ABOVE 1, INDICATING A GOOD SIGNAL AND WAVEFORM." "THE CLINICIANS OBSERVED A SIGNIFICANT DISCREPANCY BETWEEN THE BLOOD GAS MEASUREMENT AND THE SPO2 MEASUREMENT." THE SPO2 MEASUREMENT FROM THE SENSOR WAS 99% AND THE ABG SO2 MEASUREMENT WAS 83.7%. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED "THE SENSOR STOPPED WORKING WHEN THE PATIENT WAS CONNECTED, BUT THERE WAS NO BREAKAGE ON THE DEVICE. THIS TYPE OF SENSOR HAS A HIGHER IMPEDANCE, RESULTING IN A SATURATION READING APPROXIMATELY 8-10 POINTS LOWER THAN ARTERIAL BLOOD GAS ANALYSIS. THIS HAS BEEN REPORTED SEVERAL TIMES BY MY TEAM. THE PERFUSION SIGNAL IS ABOVE 1, INDICATING A GOOD SIGNAL AND WAVEFORM." "THE CLINICIANS OBSERVED A SIGNIFICANT DISCREPANCY BETWEEN THE BLOOD GAS MEASUREMENT AND THE SPO2 MEASUREMENT." THE SPO2 MEASUREMENT FROM THE SENSOR WAS 99% AND THE ABG SO2 MEASUREMENT WAS 83.7%. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2584980 RD SET OXIMETER DQA MASIMO - 15750 ALTON PKWY 4052 22M5H 00843997014298

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female