MAUDE Adverse Event Report: MMJ SA DE CV (USD) NELLCOR; OXIMETER

Model Number	MAX-I-I
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a low spo2 reading was observed during the use of an o2 sensor applied to a patient's foot in natural lighting and secured with supplemental tape.The nurse on duty noted particularly low values on a monitor using the sensor, with a reading of 79.However, the child was not agitated and did not appear to be in pain.The nurse checked the child's values with another portable monitor and a generic sensor, obtaining a reading of 99.There was a 20-point difference between the two values.It was requested that the reported sensor box no longer be used, and another box of sensors was sent to the customer.The patient was transferred to another hospital.There was no patient injury.
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: g3, h3, h6 correction: b5, d4 (lot#242180134h).H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection of the returned photos noted two different monitors reading different values.It was reported that a low spo2 reading was observed during the use of an o2 sensor applied to the patient's foot.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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 a low spo2 reading was observed during the use of an o2 sensor applied to the patient's foot in a hospital setting with natural lightning and secured with supplemental tape.The nurse on duty noted particularly low values on a monitor using the sensor, with a reading of 79.The patient was described as calm and not in visible distress.To verify the accuracy of the reading, the nurse used a portable monitor with a generic sensor from another brand of sensor, which displayed a significantly higher value of 99, indicating a 20-point discrepancy.The patient¿s skin condition and circulatory status were described as okay.Following the event, the sensor box was removed from use, and a replacement box of sensors was sent to the customer.The patient was subsequently transferred to another hospital.There was no patient injury.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21228761
• Report Number: 2936999-2025-00035
• Device Sequence Number: 7559667
• Product Code: DQA
• UDI-Device Identifier: 20884522041277
• UDI-Public: 20884522041277
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K012891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: MAX-I-I
• Device Catalogue Number: MAX-I-I
• Device Lot Number: 242180134H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male