MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND NELLCOR; OXIMETER

Model Number	PM1000N
Medical Device Problem Codes	Failure to Analyze Signal (1539); Low Readings (2460); Misassembly During Maintenance/Repair (4054)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during use, the device showed an absence of spo2 readings, repeated monitor signal dropouts, plethysmographic pattern dropouts, and a signal dropout lasting approximately five seconds (with spo2 values in the high 90s prior to this).The monitor then turned itself off and rebooted, causing a delay in monitoring for a few minutes.Although the monitor had previously undergone several repairs and a software update, the issues persisted.The monitor was replaced.No patient complications have been reported as a result of this event.
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: d9, g3, h3, h4, h6 correction: d4 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functionally, the unit did not recognize the patient interface cable, restarted by itself and displaying error.It was reported that the device showed an absence of spo2 readings, repeated monitor signal dropouts, plethysmographic pattern dropouts, and a signal dropout lasting approximately five seconds (with spo2 values in the high 90s prior to this).The monitor then turned itself off and rebooted, causing a delay in monitoring for a few minutes.Although the monitor had previously undergone several repairs and software update, the issues persisted.The reported issues were confirmed.The most likely cause was traced to a component failure and age of the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23977892
• Report Number: 8020893-2026-00002
• Device Sequence Number: 10608871
• Product Code: DQA
• UDI-Device Identifier: 10884521182530
• UDI-Public: (01)10884521182530(17)391231
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: PM1000N
• Device Catalogue Number: PM1000N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2025
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2016
• 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