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

Model Number	SWU-2009
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a patient using a smiths medical level 1® snuggle warm® blanket sustained burn marks.Reported red areas and spots of darker red were noted.There were no further adverse effects reported.
Additional Manufacturer Narrative
Other, other text: this mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.Photos were received for evaluation and the manufacturing process was reviewed.Visual inspection of the photos observed burn marks on the patient.However, the blanket is not shown on the picture to confirm if the blanket presents any sign of damage or burning marks that could affect the patient.During a review of the manufacturing process, in order to verify there are no situations or practices that could create the event as described.A four hour functional test is made on a four hour intervals to four different samples during the period of the production run using a calibrator equators.No discrepancies were found during the audit.The blankets are inspected according to the sample plan stated in procedure.Testing and inspections were performed at machine start-up and at two hour intervals during production.Burst testing and four hour performance testing was done at four hour intervals.Internal pressure testing completed hourly, also after sample after breaks in the production run.The root cause of the issue could not be determined.

• Brand Name: LEVEL 1® SNUGGLE WARM® BLANKETS
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; s.a. de c.v.; a d no.4 parque industrial int; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7284237
• Report Number: 3012307300-2018-00329
• Device Sequence Number: 10798828
• Product Code: DWJ
• UDI-Device Identifier: 10610586043383
• UDI-Public: 10610586043383
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K141686
• Number of Events Summarized: 1
• Summary Report (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): 10/28/2022

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 Expiration Date: 09/01/2020
• Device Model Number: SWU-2009
• Device Catalogue Number: SWU-2009
• Device Lot Number: 3454437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2017
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown