MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA WARMTOUCH; SYSTEM, THERMAL REGULATING

Model Number	5030810
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device caused burned on the patient's both buttocks.Patient was laid on top of the blanket, instead of blanket being draped on top of her.Then urinated onto blanket during the procedure.
Additional Manufacturer Narrative
D10 concomitant product: ccalima22, ccalima22 calima blower 220-240v (serial#: (b)(6) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: a2, a4, b5, g3.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the blanket was functioning correctly prior to and during the procedure.The patient was laid on top of the blanket, instead of the blanket being draped on top of the patient.Then the patient urinated onto the blanket, which caused burns on the patient's buttocks.The blanket temperature was set to 42 degrees celsius halfway through to 38 degrees celsius and was with the patient for two hours and 30 minutes.There were no signs of burns after the procedure and noticed the following day.The patient was referred to plastics, and the wound was cleaned.

• Brand Name: WARMTOUCH
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer (Section G): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22771418
• Report Number: 9610849-2025-00032
• Device Sequence Number: 9585607
• Product Code: DWJ
• UDI-Device Identifier: 20884521061795
• UDI-Public: 20884521061795
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K913016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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 Model Number: 5030810
• Device Catalogue Number: 5030810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/05/2025
• 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 Age: 10 YR
• Patient Sex: Female
• Patient Weight: 22 KG