MAUDE Adverse Event Report: ST PAUL LEVEL 1; SYSTEM, THERMAL REGULATING

Model Number	SWU-2010
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that during use of a smiths medical level 1 snuggle warm blankets convective warming system the patient was noted to be burned.It was reported that the burns were located on the body near where the hose's connection port was and that "medical treatment" was performed.There were no further reported adverse effects.

• Brand Name: LEVEL 1
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 7652836
• Report Number: 3012307300-2018-02522
• Device Sequence Number: 14326606
• Product Code: DWJ
• UDI-Device Identifier: 10610586043390
• UDI-Public: 10610586043390
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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?: No
• Device Model Number: SWU-2010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 06/29/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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