MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 EQUATOR BLOWERS; SYSTEM, THERMAL REGULATING

Model Number	EQ-5000
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the temperature doesn't rise.Event occurred before patient use, during testing.There was no patient involvement and no patient harmed reported.
Additional Manufacturer Narrative
B3: event date unknown.H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
One device was received for investigation.The reported issue was confirmed during functional testing when the device failed to heat within specification.Additionally, a hose disconnect alarm was activated during occlusion testing.The investigation traced the issue to the device heater which was determined to be faulty.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The device heater was replaced, and the device passed all testing.

• Brand Name: LEVEL 1 EQUATOR BLOWERS
• 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: 21132300
• Report Number: 3012307300-2025-00492
• Device Sequence Number: 7516718
• Product Code: DWJ
• UDI-Device Identifier: 50695085850005
• UDI-Public: (01)50695085850005(11)190313
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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?: Yes
• Date Returned to Manufacturer: 12/19/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2019
• 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