MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 SNUGGLE WARM BODY BLANKET; SYSTEM, THERMAL REGULATING

Catalog Number	SWU-2113
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's skin was reddened after a level 1 snuggle warm body blanket (set at a temperature of 40 c) was used in an operation.

• Brand Name: LEVEL 1 SNUGGLE WARM BODY BLANKET
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7584159
• Report Number: 3012307300-2018-02219
• Device Sequence Number: 1759968
• Product Code: DWJ
• UDI-Device Identifier: 10610586043475
• UDI-Public: 10610586043475
• 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
• Report Date (Section B): 06/08/2018

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: No Information
• Device Catalogue Number: SWU-2113
• 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: 05/14/2018
• Initial Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1