MAUDE Adverse Event Report: MEDIANA CO. LTD. NELLCOR; OXIMETER

Model Number	10005941-SG
Medical Device Problem Codes	Incorrect Measurement (1383); Low Readings (2460)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
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
According to the reporter, the baby's blood oxygen saturation needed to be tested immediately after birth to check for insufficient oxygen supply.If the saturation was too low, symptoms such as difficulty breathing and a purple complexion could occur, affecting the newborn's health.When the pulse oximeter was used to monitor the baby, it consistently showed readings between 70% and 80%.The pediatrician suspected poor contact or that the newborn was too small, so the device was kept on, but it still only showed around 80%, even though the baby was crying loudly.The doctor then used an ecg monitor, which showed readings above 90%.Based on the doctor's experience, on-site observation, and auscultation, the baby was judged to be healthy.After two hours of observation with no signs of discomfort, the baby was transferred to the ward with the mother for further testing.There was no reported patient outcome.
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
According to the reporter, the baby's blood oxygen saturation needed to be tested immediately after birth to check for insufficient oxygen supply.If the saturation was too low, symptoms such as difficulty breathing and a purple complexion could occur, affecting the newborn's health.When the pulse oximeter was used to monitor the baby, it consistently showed readings between 70% and 80%.The pediatrician suspected poor contact or that the newborn was too small, so the device was kept on, but it still only showed around 80%, even though the baby was crying loudly.The doctor then used an ecg (electrocardiogram) monitor, which showed readings above 90%.Based on the doctor's experience, on-site observation, and auscultation, the baby was judged evaluated to be healthy.After two hours of observation with no signs of discomfort, the baby was transferred to the ward with the mother for further testing.There was no reported patient harm.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 00000 ; KS 00000
• Manufacturer (Section G): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 00000 ; KS 00000
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20841760
• Report Number: 2936999-2024-01827
• Device Sequence Number: 7984322
• Product Code: DQA
• UDI-Device Identifier: 10884521171534
• UDI-Public: 10884521171534
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120773
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: 10005941-SG
• Device Catalogue Number: 10005941-SG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/06/2025
• Date Device Manufactured: 12/20/2018
• 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 Age: 1 DA
• Patient Sex: Male