MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 SNUGGLE WARM ADULT FULL-BODY CONVECTIVE WARMING BLANKET; SYSTEM, THERMAL REGULATING

Catalog Number	SWU-2001
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device couldn't be heated up to the top, and only heated halfway.This occurred during infusion at the facility.There was patient involvement, and no harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: two open devices out of their original packaging were received for investigation, along with instructions for use (ifu) that identified the lot number as 4457269.Samples were visually inspected with unaided eye, and it was observed that button seals and bars to the left of the hose card were separated.Perforations were visually inspected and were found with good appearance, no occlusion or damages were observed.Performance testing was conducted.The returned samples were found defective during performance test as the samples do not inflate as expected (warm air should be distributed inside the sealed bars).The portion where the seals were detached but not open was inflated causing an air balloon, which did not allow the warm air flow appropriately to the bottom of the blankets.Internal pressure testing was conducted.Samples failed internal pressure test as detached seals caused a balloon of air that did not allow appropriate distribution of air, causing it not to reach the correct internal pressure.The following tests were executed with the intention to duplicate the conditions of the returned blankets: blankets were inflated with a pressure 90psi to evaluate if a major pressure can cause seals to break as samples returned.Seals of blankets did not separate.Equator with additional pressure was connected simultaneously.No similar failures were observed.Blankets were inflated with a pressure of 90 psi and then a manual pressure was applied near the foot area.Seals were open and visual appearance of the seal showed a similar appearance as returned samples.Complaint is not confirmed as the most likely root cause is related to an incorrect handling of the blankets during use, as returned samples shows a correct seal appearance.In addition to this, it was observed that seals may open if a manual pressure is applied when the blanket is inflated.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: LEVEL 1 SNUGGLE WARM ADULT FULL-BODY CONVECTIVE WARMING BLANKET
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20598248
• Report Number: 9616567-2024-00145
• Device Sequence Number: 6529019
• Product Code: DWJ
• UDI-Device Identifier: 10610586043321
• UDI-Public: (01)10610586043321(17)270126(10)4457269
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2024

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: SWU-2001
• Device Lot Number: 4457269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown