MAUDE Adverse Event Report: COVIDIEN LLC NELLCOR; OXIMETER

Model Number	10005941-SG
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use, it was observed that the infant's lips were slightly cyanotic, and the transcutaneous oxygen saturation fluctuated and dropped to around 80%.However, the oxygen saturation monitor did not alarm or possibly alarmed, but the alarm sound was not noticeable and was confused with sounds from other device in the ward, causing medical staff failure to notice in time.The infant's condition improved after stimulation.
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.

• 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: 23083685
• Report Number: 2936999-2025-00462
• Device Sequence Number: 20020891
• Product Code: DQA
• UDI-Device Identifier: 10884521171534
• UDI-Public: (01)10884521171534(11)160831
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120773
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10005941-SG
• Device Catalogue Number: 10005941-SG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 09/18/2025
• Date Device Manufactured: 08/31/2016
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 5 DA
• Patient Sex: Male