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

Catalog Number	EQ-5000JP
Medical Device Problem Code	Temperature Problem (3022)
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
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 temperature was not rising.There were patient harm or adverse event reported as a result of the event.
Additional Manufacturer Narrative
H6: codes were updated.One device was returned for investigation.It was reported that the temperature is not rising", was verified by functional testing.The reported issue was caused by a broken hose sensor cable or temperature sensor.The hose was replaced to correct the issue.Eq-5000 device passed all functional tests after repair.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.It is not anticipated that the reported malfunction would result in interruption of therapy or serious injury.

• Brand Name: LEVEL 1 CONVECTIVE WARMER
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITH¿S 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: 21357359
• Report Number: 3012307300-2025-01725
• Device Sequence Number: 12874685
• Product Code: DWJ
• UDI-Device Identifier: 50695085850005
• UDI-Public: (01)50695085850005(11)190318
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: EQ-5000JP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2019
• 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