MAUDE Adverse Event Report: COVIDIEN LLC NELLCOR; OXIMETER

Model Number	PM10N
Medical Device Problem Codes	Incorrect Measurement (1383); High Readings (2459)
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, there were multiple issues with the monitor; high pulse rate readings and inconsistent spo2 readings.The pulse rate reading did not match the manual check heart pulse rate; the monitor displayed a rate reading of 165, while the manual check showed 110.The sensor and batteries were replaced with new ones, but the issue persisted.There was no patient harm.
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, there were multiple issues with the monitor; high pulse rate readings and inconsistent spo2 readings.The pulse rate reading did not match the manual check heart pulse rate; the monitor displayed a rate reading of 165, while the manual check showed 110.The sensor and batteries were replaced with new ones, but the issue persisted.There was no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 correction: b5 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the monitor displayed high pulse rate readings, such as a pulse rate of 165, while a manual check showed a heart rate of 110, and inconsistent spo2 readings were observed on the monitor.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 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the monitor displayed high pulse rate readings, such as a pulse rate of 165, while a manual check showed a heart rate of 110, and inconsistent spo2 readings were observed on the monitor during pre-operative preparation.The pulse rate reading on the monitor did not match the manual check of heart rate.A manual check of heart rate was performed for comparison with the monitor readings.To troubleshoot the issue, sensors and batteries were swapped, and sensors were tested.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: d3, d4 (udi), g3 correction: b5 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
• 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: 22397139
• Report Number: 2936999-2025-00366
• Device Sequence Number: 4901309
• Product Code: DQA
• UDI-Device Identifier: 20884521208787
• UDI-Public: (01)20884521208787(11)221219(21)MBP2229449
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2025

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 Model Number: PM10N
• Device Catalogue Number: PM10N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 09/24/2025; 12/05/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/24/2025; 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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