MAUDE Adverse Event Report: ICU Medical Healthcare Manufacturing S.A. de C.V. Continental European 230 Volt Level 1 Hotline; Warmer, Thermal, Infusion Fluid

Model Number	HL-90
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction

• 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 alemán km21.7; parque industrial monterrey; apodaca nuevo leon 66603 ; MX 66603
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50419551
• Report Number: 9616567-2026-00012
• Device Sequence Number: 13423555
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: (01)50695085820909(11)190226
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: AS
• 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,User Facility
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: Other
• Device Model Number: HL-90
• Device Catalogue Number: HL-90-INT-230
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/29/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown