BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDLINE EEG SENSOR

    MDR report key: 24423684 · Received February 23, 2026

    Report

    Report Number
    3019388613-2026-00057
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 1, 2026
    Report Date
    January 29, 2026
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    OLW
    UDI-DI
    10843997011775
    PMA / PMN Number
    K203113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: DEVICE EVALUATION IS ANTICIPATED. AT THE CONCLUSION OF OUR INVESTIGATION OR IF NEW INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. E1. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS; ZIP CODE IS AS FOLLOWS: (B)(6).

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: THE RETURNED SENSOR WAS EVALUATED. THE SENSOR WAS FOUND TO HAVE AN OPEN TRACE AT THE TIP OF THE SENSOR CONNECTOR. THE RETURNED SENSOR WAS USED; THEREFORE, ACCURACY TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE REPLICATED DURING TESTING. B3. CORRECTED "EVENT DATE" FROM 01/01/1901 TO 01/01/2026. E1. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS; ZIP CODE IS AS FOLLOWS: (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING ANESTHESIA, VALUES INDICATIVE OF AN AWAKE STATE WERE OBSERVED. AFTER REPLACEMENT OF THE DISPOSABLE COMPONENTS, VALUES CONSISTENT WITH ANESTHESIA WERE OBSERVED. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING ANESTHESIA, VALUES INDICATIVE OF AN AWAKE STATE WERE OBSERVED. AFTER REPLACEMENT OF THE DISPOSABLE COMPONENTS, VALUES CONSISTENT WITH ANESTHESIA WERE OBSERVED. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449295 SEDLINE EEG SENSOR ELECTROENCEPHALOGRAPH OLW MASIMO - 15750 ALTON PKWY 4248 25F03 10843997011775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown