TCM 4 SERIES ETX BASE UNIT
Received Dec 10, 2025 · Event occurred Dec 3, 2025
Report 3002807968-2025-00146 · MDR key 23766424
Device
Generic name
Tcm 4 Series Etx Base Unit
Manufacturer
Radiometer Medical ApsModel number
391-880Catalog number
391-880
Product problems
- Computer Software Problem
- Computer Software Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DATE OF EVENT IS ESTIMATED.
Description of Event or Problem
RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, THE TCM 4 SERIES ETX BASE UNIT (SERIAL NUMBER (B)(6) COMPLETES CALIBRATION SUCCESSFULLY AND DISPLAYS "READY." ELECTRODES ARE APPLIED TO THE PATIENT'S SKIN FOR MONITORING, AND MEASUREMENTS APPEAR ON THE SCREEN AS EXPECTED. HOWEVER, AFTER CONTINUOUS MONITORING FOR A PERIOD (AS SHORT AS A FEW MINUTES OR AS LONG AS 10-20 MINUTES), THE SCREEN SUDDENLY SHOWS "GENERAL ERROR," AND THE MACHINE STOPS MONITORING. PREVIOUSLY RECORDED DATA IS NOT LOST; IT IS SAVED IN THE PATIENT DATABASE.