MAUDE Adverse Event Report: ICU MEDICAL, INC LEVEL 1 CONVECTIVE WARMER; SYSTEM, THERMAL REGULATING

Catalog Number	L1-CW-220V
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D3: mfg establishment name; icu medical, inc.Device evaluation: one device was received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.Functional testing and visual inspection performed during analysis.The customer reported complaint could be confirmed.The root cause was due to a faulty warming hose.The hose was replaced.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the device did not work properly in the instance that it was not warming up.There were no patient harms or adverse events reported as a result of the event.

• Brand Name: LEVEL 1 CONVECTIVE WARMER
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): ICU MEDICAL, INC; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21415391
• Report Number: 3012307300-2025-02026
• Device Sequence Number: 15752947
• Product Code: DWJ
• UDI-Device Identifier: 15019517121551
• UDI-Public: (01)15019517121551
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• PMA/510(K) Number: K181699
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: L1-CW-220V
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2018
• 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