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

Catalog Number	L1-CW-220V
Medical Device Problem Codes	Circuit Failure (1089); Overheating of Device (1437); Unexpected Shutdown (4019); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for investigation.Due to this, there was no evidence to confirm the reported customer complaint or to determine probable cause.Review of the service history showed that the device had not been sent in for service in the last 12 months.
Event or Problem Description
It was reported that the warmer was stopping and that the over-temperature and the maintenance indicators were rapidly blinking.The device was being used on a patient while this happened.No patient harm or medical intervention was required.
Additional Manufacturer Narrative
H2) device evaluation: d9 date returned to manufacturer: 5/2/2025.H3, h6: the device was returned for root cause analysis and the investigation findings concluded after visual inspection, functional testing, and event history log (ehl) review, the customer problem was duplicated.The device was found in normal used conditions with no cracks.The ehl showed a "thermal_cutout" alarm.The cause of the customer reported problem was a defective alternating current (ac) printed circuit board assembly (pcba).Service history review identified there was no indication that the complaint was related to a service of the device within the review period.The device passed all functional and electrical safety tests.

• Brand Name: LEVEL 1 CONVECTIVE WARMER
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21229499
• Report Number: 3012307300-2025-01070
• Device Sequence Number: 8285381
• Product Code: DWJ
• UDI-Device Identifier: 50695085850005
• UDI-Public: (01)50695085850005(11)190917
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K181699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 05/18/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2019
• 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