MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 ADULT 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	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the adhesive peeled off, and when air is blown on it, only one part expands, so the heat does not reach the top.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: six used samples outside their original package were received for evaluation.No lot number identification.Regarding customer complaint description: "the adhesive has peeled off, and when air is blown on it, only one part expands, so the heat does not reach the top.", samples were tested as follows: returned samples were visually inspected.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.However, the seal showed the evidence of appropriate melting.Regarding customer complaint description ".The heat does not reach the top." it was observed that perforations were visually inspected and were found with good appearance, no occlusion or damage were observed.Additionally, the bar channels inflate all the way from top to bottom.Procedure for internal pressure and performance 4 hours tests for blankets manufacturing.Returned samples was 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 ballon which did not allow the warm air flow appropriately to the bottom of the blankets.Procedure for internal pressure and performance 4 hours tests for blankets manufacturing.Samples 1, 2, 3 & 5 failed internal pressure test as detached seals cause a ballon of air that does not allow appropriate distribution of air causing not to reach the correct internal pressure.Two (2) available retain samples of lot 4467606 were tested.Performance test - both samples acceptable.Internal pressure test - results 0/2.Sample 1: 1.44 cmh20, sample 2: 1.68 cmh2o.Burst test - both samples acceptable.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.Result: seals of blankets did not separate.- equator with additional pressure was connected simultaneously.Results: 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.Results: seals were open and visual appearance of the seal show a similar appearance as returned samples.Complaint is not confirmed as the most likely root cause could related to an incorrect handling of the blankets during used 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 device history record could not be completed as no lot number was received.

• Brand Name: LEVEL 1 ADULT 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: 20400313
• Report Number: 9616567-2024-00134
• Device Sequence Number: 6518169
• Product Code: DWJ
• UDI-Device Identifier: 10610586043321
• UDI-Public: (01)10610586043321
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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