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

Model Number	L1-CW-120V
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.No problems or issues were identified during the device history record review.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Product was received device in with no line cord or hose.Multiple errors were found in event history log.Investigation confirmed customer's reported problem.Measured heater and got no reading.When opening up the heater founded that the heater was burnt.The root cause of the reported issue was determined to be the design.The ac distribution board and heater are known to be susceptible to the melted heat failure mode.No action taken due to the condition of the device.It is deemed beyond economical repair and will be scrapped.
Event or Problem Description
It was reported that the device is presenting with intermittent heating.No patient injury was reported.

• Brand Name: LEVEL 1 BLOWERS CONVECTIVE WARMING
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16475411
• Report Number: 3012307300-2023-01960
• Device Sequence Number: 7250517
• Product Code: DWJ
• UDI-Device Identifier: 15019517121551
• UDI-Public: 15019517121551
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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: L1-CW-120V
• Device Catalogue Number: L1-CW-120V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown