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

Model Number	MAXN
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Burn(s) (1757); Blister (4537)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during use, the device had pressure wound found at the site of sensor placement, noticed by nurse in the nicu.There was a burn and blister seen on the patient's foot and it was deemed that it was from the light sensor.Customer thought that the light  on the sensors was warm enough to burn through their unit.Patient was isolated.The sensor stayed in place at the site of skin integrity issue for 3 hours, and was on supine position.The skin integrity issue was visible immediately after sensor was removed.The patient had two burn like markings where the sensors are on the foot.Skin checked every three hours on three other site and lasted for one week.Plastic surgery and wound care nurse were consulted.Skin was treated through open air.The patient recovered but markings was still on the foot.Patient was premature, and had no existing allergies and skin conditions.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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
According to the reporter, during use, the device had a pressure wound found at the site of sensor placement, as noticed by the nurse in the nicu.There was a burn and blister seen on the patient's foot, and it was deemed that it was from the light sensor.The customer thought that the light on the sensors was warm enough to burn through their unit.The patient was isolated.The sensor stayed in place at the site of the skin integrity issue for 3 hours and was in the supine position.The skin integrity issue was visible immediately after the sensor was removed.The patient had two burn-like markings where the sensors were placed.The skin was checked every 3 hours on 3 other sites and lasted for 1 week.Plastic surgery and wound care nurses were consulted.The skin was treated with open air.The patient recovered, but markings were still on the foot.The patient was premature and had no existing allergies or skin conditions.

• Brand Name: NELLCOR
• 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: 15262869
• Report Number: 1282497-2022-00048
• Device Sequence Number: 12148145
• Product Code: DQA
• UDI-Device Identifier: 20884522041727
• UDI-Public: 20884522041727
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K012891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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: 03/31/2025
• Device Model Number: MAXN
• Device Catalogue Number: MAXN
• Device Lot Number: 221080120H
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 06/19/2024
• Date Device Manufactured: 04/18/2022
• 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: Female