MAUDE Adverse Event Report: COVIDIEN LLC NELLCOR; OXIMETER

Model Number	PM10N
Medical Device Problem Codes	Device Alarm System (1012); Failure to Power Up (1476); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device would not power on, exhibited case damage, and had main board components that were damaged.No audible or visible alarms were triggered for the failure.Both the front case and main board were replaced, and the system software was updated.The device arrived without any batteries.It is unknown if there was any patient involvement or complications as a result of the 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,h2,h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted found damaged to the front case and main board has components damaged.Based on the evidence available the reported conditions were confirmed.Both the front case and main board were replaced, and the system software was updated.The device arrived without any batteries.It was reported that the device would not power on, exhibited case damage, and had main board components that were damaged.No audible or visible alarms were triggered for the failure.The reported issue was confirmed.The most likely cause was was traced to a component failure.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.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: d8, h3 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted damage to the front case and the main board had components damaged.The issue was resolved by replacing the front case and the main board.It was reported that that the device would not power on, exhibited case damage, and had main board components that were damaged.No audible or visible alarms were triggered for the failure.Both the front case and main board were replaced, and the system software was updated.The device arrived without any batteries.The reported issues were confirmed.The most likely cause was traced to a component failure.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.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: 22850563
• Report Number: 2936999-2025-00425
• Device Sequence Number: 17265342
• Product Code: DQA
• UDI-Device Identifier: 20884521208787
• UDI-Public: (01)20884521208787(11)220426
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/24/2025

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
• Date Returned to Manufacturer: 08/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 10/20/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/15/2025; 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• 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