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

Model Number	5030870
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: 5016000, 5016000 wt6000 warming unit x1 (sn# (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.
Event or Problem Description
It was reported that a patient using a thermal blanket on the upper limbs, in conjunction with the warmtouch heating equipment, suffered a thermal burn on the right arm.The surrounding area turned red, and there were two spots, as if the patient's skin was loose.A scalpel was used, and the area was cleaned with alcoholic chlorhexidine.A consultation with a plastic surgeon diagnosed the injury as a thermal burn.The hospitalization was extended due to this event.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that the blanket product did not have the perimeter seals complete.It did have the welded diameter buttons.Blanket product did not have a torn inlet however this could be attributed to the disconnection of the blower.It was reported that the patient suffered a thermal burn on the right arm.The surrounding area turned red, and there were two spots, as if the patient's skin was loose.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: the files were found to contain appropriate instructions for use, cautions and warnings including the following: no free-hosing.Keep hose nozzle connected to the warmtouch¿ blanket at all times or thermal injury may occur.Possible burn or infection hazard.Do not allow blanket to come into contact with open wounds or mucous membranes.All patients¿ wounds should be covered while using the warming system.Possible patient burns.Use caution and consider discontinuing use on patients during vascular surgery when an artery to an extremity is clamped.Do not apply the warming system to ischemic limbs.Use caution and monitor closely if used on patients with severe peripheral vascular disease.Do not allow objects that are heavy enough to constrict airflow (such as cables) to drape over the blanket at the blower inlet.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.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21167281
• Report Number: 1282497-2025-00032
• Device Sequence Number: 17294085
• Product Code: DWJ
• UDI-Device Identifier: 20884521063195
• UDI-Public: 20884521063195
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K913016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5030870
• Device Catalogue Number: 5030870
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTES ON H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown