MAUDE Adverse Event Report: ICU MEDICAL, INC. LEVEL 1 HOTLINE FLUID WARMER, 390

Catalog Number	CON-HL-390
Medical Device Problem Code	Fire (1245)
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
Received one device.Visual inspection found melting located on the pcba (printed circuit board assembly) and wires connected to the terminal block.The unit had clear signs of fire damage.The fire was internal and looks to be started from the terminal block.Specifically it looks like the fire started where the power cord wires are connected to the pcba.This unit is beyond econimical repair over 60% of the major components need replacement.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.
Event or Problem Description
It was stated that device won't power on during testing.There was no patient involvement.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• Common Device Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n.; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23532478
• Report Number: 3012307300-2025-12374
• Device Sequence Number: 9140910
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: (01)10695085002796(11)101022
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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 Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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