MAUDE Adverse Event Report: COVIDIEN LLC NELLCOR; OXIMETER

Model Number	PM10N
Medical Device Problem Codes	Device Alarm System (1012); Low Readings (2460); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use, the monitor was providing low spo2 readings.The monitor was consistently reading low, displaying spo2 values of 66¿71% and pulse rates of 78¿81 bpm, regardless of the settings applied on the patient simulator.A patient simulator was used, and even when set to 95% spo2 and 140 bpm, the monitor did not reflect these values and did not alarm as expected.The patient simulator had been calibrated within the last month.Sensors were swapped, including the use of a sensor probe that was verified to be functioning properly on another monitor; however, the same low readings were observed.The readings were also compared to another unit.It was noted to check the spo2 settings, patient settings/modes, and to confirm that the correct data was being received from the device when verifying with the tester.Additionally, it was recommended to remove the device from any led lighting to rule out interference.There was no patient injury reported.
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 info: b5, g3, h6 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, the monitor was providing low spo2 readings.The monitor was consistently reading low, displaying spo2 values of 66¿71% and pulse rates of 78¿81 bpm, regardless of the settings applied on the patient simulator.A patient simulator was used, and even when set to 95% spo2 and 140 bpm.There was no visual message on the screen of "high" or "low" readings on screen, and no sound during that time of testing.The patient simulator had been calibrated within the last month.Sensors were swapped, including the use of a sensor probe that was verified to be functioning properly on another monitor; however, the same low readings were observed.The readings were also compared to another unit.It was noted to check the spo2 settings, patient settings/modes, and to confirm that the correct data was being received from the device when verifying with the tester.Additionally, it was recommended to remove the device from any led lighting to rule out interference.It was unable to have further test to this equipment because it was not registering that it has a sensor plugged into it.There was no patient injury reported.

• 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: 24889454
• Report Number: 2936999-2026-00131
• Device Sequence Number: 21288060
• Product Code: DQA
• UDI-Device Identifier: 20884521208787
• UDI-Public: (01)20884521208787(17)360911
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K141542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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 Model Number: PM10N
• Device Catalogue Number: PM10N
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/06/2026
• Date Device Manufactured: 07/13/2017
• 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
• Patient Sex: Unknown