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

Model Number	PM1000N
Medical Device Problem Codes	Image Display Error/Artifact (1304); Temperature Problem (3022); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
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 testing/maintenance, the monitor was stuck on the loading screen, exhibited an spo2 error, and emitted a burning odor.Additionally, the front casing of the device had a crack.Troubleshooting steps included swapping sensors and spo2 cords, but no change was observed.There was no patient involved.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The monitor was connected to an ac power and activated, where error code 11 displayed with message for ¿battery missing or damaged¿ during power on self test (post).The battery compartment was opened, and no battery was found inside.A known-good test battery was then installed and monitor power cycled, where it passed post with no operational issues with and without a sensor connected.Operation was maintained for a short period before being shut off.The monitor was then opened and found no signs of burns or thermal damage on any of its components.The parameter board was found to have leftover flux residue on through-hole components.The monitor was reassembled and activated for continuous, monitored operation for a period of eight hours, where no demonstration of failure was observed.The issue was resolved by replacing the spo2 board.It was reported that the monitor was stuck on the loading screen, exhibited an spo2 error, and emitted a burning odor.The reported issues could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the front casing of the monitor had a crack.The reported issue was confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: missing battery.The most likely cause for the additional condition is 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): 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21886030
• Report Number: 8020893-2025-00089
• Device Sequence Number: 18190216
• Product Code: DQA
• UDI-Device Identifier: 10884521182530
• UDI-Public: 10884521182530
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: PM1000N
• Device Catalogue Number: PM1000N
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2019
• 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