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

Catalog Number	EQ-5000JP
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.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 information becomes available.The device has not been returned to the manufacturer.
Event or Problem Description
It was reported that the connector is broken and sometimes, air does not blow out.The event occurred before patient use at the facility.
Additional Manufacturer Narrative
The suspected device was returned for evaluation.The event history log (ehl) was reviewed.The device was visually inspected.Functional and visual tests were performed and the reported issue was confirmed.The cause of the reported issue was due to a broken hose sensor cable.As a result, the equator hose was replaced.The service history review had no indication that the complaint was related to a service of the device within the review period.The device passed all functional testing after repair and was returned to the customer.

• 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: 22569536
• Report Number: 3012307300-2025-08796
• Device Sequence Number: 3993985
• Product Code: DWJ
• UDI-Device Identifier: 50695085850005
• UDI-Public: (01)50695085850005(11)140214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: EQ-5000JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown