BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAPIDPOINT 500E BLOOD GAS SYSTEM

    MDR report key: 23211409 · Received October 3, 2025

    Report

    Report Number
    3002637618-2025-00071
    Event Type
    Death
    Date Received
    October 3, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 3, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC., POC HQ
    Product Code
    CHL
    PMA / PMN Number
    K192240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INSTRUMENT MANUAL, THE SYSTEM AUTOMATICALLY CALIBRATES EVERY 30 MINUTES. A CALIBRATION MAY BE INTERRUPTED BY AN OPERATOR TO ANALYZE A PRIORITY SAMPLE. BASED ON THE INSTRUMENT LOG REVIEW, AUTOMATIC SYSTEM CALIBRATIONS ARE PERFORMING AS SCHEDULED. THERE IS NO INSTRUMENT MALFUNCTION. OPERATOR EDUCATION HAS BEEN RECOMMENDED.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THAT DURING RESUSCITATION OF A PATIENT, BLOOD ANALYSIS WAS NOT POSSIBLE DUE TO CONTINUOUS, UNINTERRUPTIBLE CALIBRATIONS OF THEIR RP500E. TESTING WAS PERFORMED ON A BACKUP INSTRUMENT RESULTING IN A DELAY IN RESULTS AND THE CUSTOMER INSTEAD TREATED THE PATIENT BLINDLY. THE CUSTOMER STATED THAT THE PATIENT PASSED BUT HAS NOT STATED IF THEY BELIEVE THE INSTRUMENT CAUSED OR CONTRIBUTED TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905085 RAPIDPOINT 500E BLOOD GAS SYSTEM RP 500E CHL SIEMENS HEALTHCARE DIAGNOSTICS, INC., POC HQ

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death