BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE PULSE OXIMETER SENSOR

    MDR report key: 24428864 · Received February 23, 2026

    Report

    Report Number
    MW5184291
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 12, 2026
    Report Date
    January 18, 2026
    Manufacturer
    CURBELL MEDICAL PRODUCTS, INC.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    O2 SATURATION MONITORS WERE PLACED IN PT CARE AREAS MEDSURG, ER, AND ORPERATING ROOM. CONCERNS WERE RAISED ON ACCURACY OF THE MONITORING. RESULTS WERE COMPARED USING A PORTABLE PULSE OXIMETER MONITOR WHICH SHOWED TWO DIFFERENT READINGS. ONCE THIS WAS DISCOVERED OXYGEN SATURATIONS WERE COMPARED BETWEEN THE CURBELL AND THE NORMALLY USED DEVICE. THE CURBELL PULSE OXIMETER WAS SHOWING A MUCH LOWER OXYGEN SATURATION. REFER TO ADD'L DOCUMENTS IN I2K. PATIENT CODE: 4580. DEVICE CODE: 1535. REFERENCE REPORTS: MW5184290, MW5184292.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484584 DISPOSABLE PULSE OXIMETER SENSOR OXIMETER DQA CURBELL MEDICAL PRODUCTS, INC. CSA027DP-P100 (10)2539

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other