MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 SNUGGLE WARM CONVECTIVE BODY BLANKET; SYSTEM, THERMAL REGULATING

Catalog Number	SWU-2001
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the warming blanket often when touching it gives an electric shock.The person who received an electric shock was the nurse.The incident occurred during removing the cover and there were no reported injuries, but the discharge is so strong that it was felt for some time.Customer also stated that there was no patient involvement.
Additional Manufacturer Narrative
No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.
Additional Manufacturer Narrative
D9: (b)(6) 2024.H3: one used unit of lot #4467606 was received for evaluation.Functional testing was performed and no user was able to identify an experience of electrostatic shock.The the blanket device is a fabric product and none of the components are designed to conduct electricity.The reported issue was not confirmed during evaluation.The device history record of reported lot 4467606 was reviewed and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.

• Brand Name: LEVEL 1 SNUGGLE WARM CONVECTIVE BODY BLANKET
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20739323
• Report Number: 9616567-2024-00165
• Device Sequence Number: 8613876
• Product Code: DWJ
• UDI-Device Identifier: 10610586043321
• UDI-Public: (01)10610586043321(17)270306(10)4467606
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K141686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: SWU-2001
• Device Lot Number: 4467606
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown