MAUDE Adverse Event Report: SMITH¿S MEDICAL ASD, INC. LEVEL 1 CONVECTIVE WARMER; SYSTEM, THERMAL REGULATING

Model Number	EQ-5000
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.One device was received for investigation.The device was visually inspected and functionally tested.The reported problem was confirmed.The cause of the event is the combustion of the internal motor, control board, and other parts.The root cause of the combustion is unknown.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.
Event or Problem Description
It was reported that the power does not turn on.There's a strange smell.Event occurred before patient use/during priming at the facility.There was no patient involvement, and no patient harmed reported.

• Brand Name: LEVEL 1 CONVECTIVE WARMER
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITH¿S MEDICAL ASD, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21631527
• Report Number: 3012307300-2025-03005
• Device Sequence Number: 18450455
• Product Code: DWJ
• UDI-Device Identifier: 50695085850005
• UDI-Public: (01)50695085850005(11)060809
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

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 Model Number: EQ-5000
• Device Catalogue Number: EQ-5000JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2006
• 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