MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 CONVECTIVE WARMER - 120 VOLT CONFIGURATION; SYSTEM, THERMAL REGULATING

Catalog Number	L1-CW-120V
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
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 operator of the device was unable to clear the over temp alarm.There were unknown patient harm or adverse effects reported as a result of the event.
Additional Manufacturer Narrative
One device was received for evaluation.Visual inspection was performed.Functional testing was unable to duplicate the reported problem.The service history review had no indication that the complaint was related to a service of the device within the review period.

• Brand Name: LEVEL 1 CONVECTIVE WARMER - 120 VOLT CONFIGURATION
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21463427
• Report Number: 3012307300-2025-02210
• Device Sequence Number: 8822160
• Product Code: DWJ
• UDI-Device Identifier: 15019517121551
• UDI-Public: (01)15019517121551(11)190109
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: Other
• Device Catalogue Number: L1-CW-120V
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2019
• 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