MAUDE Adverse Event Report: COVIDIEN LLC NELLCOR; OXIMETER

Model Number	PM100N
Medical Device Problem Codes	Device Alarm System (1012); Failure to Analyze Signal (1539)
Health Effect - Clinical Codes	Cyanosis (1798); Encephalopathy (1833); Ischemia (1942); Brain Injury (2219)
Date of Event	02/19/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient had been using the monitor, which was connected to the device and appeared to be functioning as expected when the video monitor was checked at 3:00 am.However, by 7:00 am, the oxygen saturation level had dropped to 50, and the monitor was flashing but not alarming.The patient had turned blue, prompting cpr to be initiated and 911 to be called.The patient was resuscitated and transported to the hospital, where he was diagnosed with hypoxic-ischemic encephalopathy (hie), a brain injury caused by insufficient oxygen supply.Unfortunately, the patient was rendered brain-dead as a result of the incident-from (b)(6)-it was reported that during use, the unit flashed but with no audible sound when the patient¿s spo2 went down to 50% and the patient turned blue.The mother started cpr and 911 was called.The son was resuscitated and was taken to the hospital but was later diagnosed with hypoxic-ischemic encephalopathy (hie) that rendered the patient brain dead.The unit was reported not in sleep study mode and had audible alarm prior to the event.Duplicate of (b)(6).
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.
Additional Manufacturer Narrative
Additional information: b5,h1,h2.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 patient had been using the monitor, which was connected to the device and appeared to be functioning as expected when the video monitor was checked at 3:00 am.The monitor settings were: hr high 160, hr low 80, o2 high 100, and o2 low 89.However, by 7:00 am, the oxygen saturation level had dropped to 50, and the monitor was flashing but not alarming.The patient had turned blue, prompting cpr to be initiated and 911 to be called.The patient was resuscitated and transported to the hospital, where he was diagnosed with hypoxic-ischemic encephalopathy (hie), a brain injury caused by insufficient oxygen supply.Unfortunately, the patient was rendered brain-dead as a result of the incident.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): COVIDIEN LLC; 6135 gunbarrel ave; boulder,co 00000 ; KS 00000
• Manufacturer (Section G): COVIDIEN LLC; 6135 gunbarrel ave; boulder,co 00000 ; KS 00000
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22705536
• Report Number: 2936999-2025-00407
• Device Sequence Number: 13014494
• Product Code: DQA
• UDI-Device Identifier: 10884521196728
• UDI-Public: (01)10884521196728(17)361013
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K142865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: PM100N
• Device Catalogue Number: PM100N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 12/29/2025
• Date Device Manufactured: 08/14/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Disability; Life Threatening
• Patient Age: 6 MO
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White