MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE; WARMER, THERMAL, INFUSION FLUID

Catalog Number	HL-90-INT-230
Medical Device Problem Codes	Device Alarm System (1012); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that there is a temperature alarm occurred in the surgery room.There was a therapy delay, and the device was replaced.There was no patient involvement.
Additional Manufacturer Narrative
One device was returned for analysis of complaint of temperature alarm.Service history review identified the complaint was not related to a previous service of the device within the review period.Visual and functional testing was performed.No alarm was triggered.The heater showed an excessively high insulation resistance value during the electrical test and was therefore replaced.No malfunctions were detected during operation.The heating system was replaced because it failed the electrical safety test.However, this is not the cause of the alarm.Probable cause of complaint was not determined.

• Brand Name: CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; carretera miguel aleman km; parque industrial monterrey; apodaca nl 66603 ; MX 66603
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23544463
• Report Number: 3012307300-2025-12444
• Device Sequence Number: 9448992
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: (01)50695085820909(11)191126
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: Other
• Device Catalogue Number: HL-90-INT-230
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2019
• 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