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

Model Number	PM100N
Medical Device Problem Codes	Image Display Error/Artifact (1304); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra-operative use, the unit displayed error eee010 and low readings were observed.The reading was consistently off by -10, reading lower than expected.The sensor was applied to the finger, toes, and foot, held in place with medical tape, and was brand new, having been in use for one day.Troubleshooting steps included swapping out sensors with known working and new sensors, but no change was observed.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, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Troubleshooting steps included swapping out sensors with known working and new sensors, but no change was observed.It was reported that the unit displayed error eee010 and low readings was observed.The reading was consistently off by -10, which was lower than expected.The sensor was applied to the finger, toes, and foot, held in place with medical tape, and was brand new, having been in use for one day.The reported issue was not confirmed.The most likely cause was not determined from the available information.The evaluation detected an unreported condition: backup battery that had no relationship to the reported condition.The most likely cause for the additional condition 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.
Event or Problem Description
It was reported that during intra-operative use, the unit displayed error eee010 and low readings were observed.The reading was consistently off by -10, reading lower than expected.The sensor was applied to the finger, toes, and foot, held in place with medical tape, and was brand new, having been in use for one day.Troubleshooting steps included swapping out sensors with known working and new sensors, but no change was observed.No patient complications have been reported as a result of this event.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 26382 ; KS 26382
• Manufacturer (Section G): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 26382 ; KS 26382
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21985582
• Report Number: 2936999-2025-00232
• Device Sequence Number: 20970618
• Product Code: DQA
• UDI-Device Identifier: 10884521196728
• UDI-Public: 10884521196728
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K142865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PM100N
• Device Catalogue Number: PM100N
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 08/23/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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