BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 23156677 · Received September 26, 2025

    Report

    Report Number
    2016493-2025-118133
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    September 5, 2025
    Report Date
    December 12, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    CCK
    UDI-DI
    10885403520761
    PMA / PMN Number
    K031741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. STATED ¿UNABLE TO CALIBRATE¿ ISSUE COULD NOT BE CONFIRMED. -DEVICE FAILED VERIFICATION AS RECEIVED. DEVICE WAS CALIBRATED AND PASSED VERIFICATION -COULD NOT DUPLICATE THE ISSUE OF ¿COULD NOT CALIBRATE¿, NFF. -DEVICE FI REPORT UPLOADED TO SALESFORCE. THIS REPORT LISTS IMDRF ANNEX A, C, D, AND G CODES THAT ARE REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING SERVICING. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. STATED ¿UNABLE TO CALIBRATE¿ ISSUE COULD NOT BE CONFIRMED. DEVICE FAILED VERIFICATION AS RECEIVED. DEVICE WAS CALIBRATED AND PASSED VERIFICATION. COULD NOT DUPLICATE THE ISSUE OF ¿COULD NOT CALIBRATE¿, NFF. DEVICE FI REPORT UPLOADED TO SALESFORCE. THIS REPORT LISTS IMDRF ANNEX A, C, D, AND G CODES THAT ARE REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING SERVICING. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD UNABLE TO CALIBRATE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD UNABLE TO CALIBRATE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD UNABLE TO CALIBRATE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2111974 ALARIS SYSTEM ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK CAREFUSION SD 8300 10885403520761

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown