MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA NELLCOR OXYSOFT; OXIMETER

Model Number	OXYSOFTNJ
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, during use, an infant admitted to the nicu who was born weighing just under 2,400g had experienced skin damage and detachment on the third day.The damage had corresponded to the sensor's light-emitting part.The image had shown the lowest damaged part among the three parts on the right foot.There had also been pressure sores due to pressure, but the situation was identified as burns.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.It was reported that during use, an infant was admitted after experiencing skin damage and detachment on the third day.The damage corresponded to the light-emitting part of the sensor.An image showed that the most severely damaged area was one of three affected parts on the right foot.Pressure sores were also present due to prolonged pressure, but the condition was identified as burns.Although the skin damage was not definitively diagnosed as a burn, it was described as a "degree i" burn, as it had not reached the dermis.The reported issue could not be confirmed the most likely cause could not be identified because no related problem was detected with the device.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.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: NELLCOR OXYSOFT
• Common Device Name: OXIMETER
• 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: 21977266
• Report Number: 1282497-2025-00305
• Device Sequence Number: 9274126
• Product Code: DQA
• UDI-Device Identifier: 10884521818989
• UDI-Public: (01)10884521818989(17)260630(10)231840220H
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K212555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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 Expiration Date: 06/30/2026
• Device Model Number: OXYSOFTNJ
• Device Catalogue Number: OXYSOFTNJ
• Device Lot Number: 231840220H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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