MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEMS; SYSTEM, THERMAL REGULATING

Catalog Number	SW-2003
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	07/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a patient sustained a first degree burn on the left forearm with the use of a level 1® snuggle warm® blankets convective warming systems.This was after 4 hours and 30 minutes of use of the device.The patient was positioned in a supine position with the arms crossed.The operating temperature was 40 degrees celsius.Clinicians ensured that the installation was non-compressive.No other adverse health outcomes were reported.
Additional Manufacturer Narrative
Three level 1® snuggle warm® blankets were returned for investigation.One of the samples was received in used conditions, while the other two were received in their original packaging.A visual inspection was performed on the three samples.The used sample presented an 80mm tear in the middle section.Functional testing was performed on the two unused samples and no anomalies were detected during use, the blankets exhibited good performance.A manufacturing review of a similar device was performed and no discrepancies were found.The complaint could not be confirmed.
Additional Manufacturer Narrative
One of the samples was received in used conditions, while the other two were received in their original packaging.A visual inspection was performed on the three samples.The used sample presented an 80mm tear in the middle section.Functional testing was performed on the two unused samples and no anomalies were detected during use, the blankets exhibited good performance.A manufacturing review of a similar device was performed and no discrepancies were found.The complaint could not be confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.For all enquires or follow up questions related to the record, do not use (b)(6) located in section g1 please direct those to the following: (b)(6) corrected data: g7: follow-up number.

• Brand Name: LEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEMS
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; avenida calidad no. 4; parque industrial internaciona; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6828192
• Report Number: 3012307300-2017-01972
• Device Sequence Number: 1522003
• Product Code: DWJ
• UDI-Device Identifier: 30695085000031
• UDI-Public: 30695085000031
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K011907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2018

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: SW-2003
• Device Lot Number: 3388590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 02/02/2018; Not provided
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 03/12/2024; 02/20/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LEVEL 1® EQUATOR® CONVECTIVE WARMING; LEVEL 1® EQUATOR® CONVECTIVE WARMING
• Patient Age: 51 YR
• Patient Sex: Unknown
• Patient Weight: 53 KG