MAUDE Adverse Event Report: SMITH¿S MEDICAL ASD, INC. LEVEL 1 CONVECTIVE WARMER EQ-5000 BLOWER; SYSTEM, THERMAL REGULATING

Catalog Number	EQ-5000JP
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the temperature did not reach the set value.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.H3.Reason device not evaluated by mfg: other; device was 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 received for evaluation.Visual inspection found no abnormalities.Functional testing was unable to duplicate or confirm the reported problem.The heater was replaced as a preventative measure.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 EQ-5000 BLOWER
• 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: 20652331
• Report Number: 3012307300-2024-13053
• Device Sequence Number: 20887541
• Product Code: DWJ
• UDI-Device Identifier: 50695085850005
• UDI-Public: (01)50695085850005(11)180613
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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: 10/31/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 12/01/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2018
• 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