MAUDE Adverse Event Report: RADIOMETER MEDICAL APS TCM 4 SERIES ETX BASE UNIT

Model Number	391-880
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Date of event is estimated.

• Brand Name: TCM 4 SERIES ETX BASE UNIT
• Common Device Name: TCM 4 SERIES ETX BASE UNIT
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: bernarda radoncic ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 23766343
• Report Number: 3002807968-2025-00145
• Device Sequence Number: 21486654
• Product Code: LKD
• UDI-Device Identifier: 05700693918808
• UDI-Public: (01)05700693918808
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 391-880
• Device Catalogue Number: 391-880
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown