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

Model Number	D25
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Pressure Sore/Ulcer (2326)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
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, the device caused a low temperature burn on the forehead.The skin side where the sensor was attached appeared to be covered in redness.
Event or Problem Description
According to the reporter, during use, the sensor caused a low temperature burn on the forehead of the patient where it was applied.The patient's skin was dry and partially peeled due to the influence of the anticancer drug.The sensor was used for two or three days in a row and was not replaced.After a day or two, redness appeared, a feeling of heat was confirmed, and infection was suspected.There was no particular treatment, and it became tolerant in one week.
Additional Manufacturer Narrative
Additional information: b5, d4 (model #, catalog #, udi), g3, g4 (510k).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: b1, b2, g3, h1, h6 (ime, fdp) new information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a serious injury.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
Correction: b5 additional information: 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
According to the reporter, during use, there was redness observed on the fingertips, and patient had feeling of heat.At the time of discovery, it was confirmed that the fingertips were wet.The sensor was used for two or three days in a row and was not replaced.The patient's skin was dry and partially peeled due to the influence of the anticancer drug.The patient was able to tolerate it with no particular treatment in one week.

• 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: 19560760
• Report Number: 1282497-2024-00167
• Device Sequence Number: 14655508
• Product Code: DQA
• UDI-Device Identifier: 30884522000844
• UDI-Public: 30884522000844
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K993637
• 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,Followup,Followup
• Report Date (Section B): 09/27/2024

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: D25
• Device Catalogue Number: D25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 06/15/2024; 07/03/2024; 09/26/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/03/2024; 07/08/2024; 09/27/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown