MAUDE Adverse Event Report: RADIOMETER MEDICAL APS TCM 4 MONITOR

Model Number	391-880
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, on (b)(6) 2025 during the monitoring of the patient tcpo2 and tcpco2, the tcm monitor (serial number: (b)(6) display panel suddenly shut down and could not be restarted.This resulted in the inability to continue the monitoring of the patient, leading to an arterial blood sample drawn instead.
Additional Manufacturer Narrative
According to radiometer investigation the issue is most likely due to voltage fluctuations in the customer's infrastructure.But the exact root cause is unknown.

• Brand Name: TCM 4 MONITOR
• Common Device Name: TCM 4 MONITOR
• 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: pearlyn pah ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 21750030
• Report Number: 3002807968-2025-00048
• Device Sequence Number: 21372742
• Product Code: LKD
• UDI-Device Identifier: 05700693918808
• UDI-Public: (01)05700693918808
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093154
• 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): 05/13/2025

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: 03/21/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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