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

Catalog Number	SWU-2001
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that following use of a smiths medical level 1® smiths medical level 1® snuggle warm® blanket phlycten was noted to the patient's right forearm.Subsequently, vaseline gauze and biafine cream was applied to the burn.No further adverse patient effects were reported.

• Brand Name: LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8848652
• Report Number: 3012307300-2019-03895
• Device Sequence Number: 11362033
• Product Code: DWJ
• UDI-Device Identifier: 10610586043321
• UDI-Public: 10610586043321
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SWU-2001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention