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

Model Number	EQ-5000
Medical Device Problem Codes	Break (1069); Insufficient Heating (1287); No Device Output (1435)
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 won't rise, the equipment won't work, and the hose is broken".There was no patient involvement and reporter confirmed that there were no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.H3: device not returned to manufacturer.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.
Additional Manufacturer Narrative
One device was returned for evaluation in used condition.The customer's reported problem was not verified during functional testing.The reported issue did not reproduce, and the cause was unable to be determined.At the customer's request, the product was returned to the customer without repair.Therefore, no action was taken.

• 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: 21162256
• Report Number: 3012307300-2025-00775
• Device Sequence Number: 9530149
• Product Code: DWJ
• UDI-Device Identifier: 50695085850005
• UDI-Public: (01)50695085850005
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2024
• Supplement Date Received by Manufacturer: 06/22/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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