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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: max-i-i, max-i-i max inf o2 sensor i20 3-20 kg, (lot #231700140h) h3 evaluation summary: the customer¿s reported issue could not be confirmed.Although the device was returned for investigation, it was lost during transit to the testing facility.If the product is found or returned for investigation, the file will be re-opened and an additional report sent with the updated investigation results.This regulatory report is being submitted due to retrospective review through capa 624392.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, the sensor had low spo2 reading that could be seen on different monitors.The first sensor was placed at the patient's foot and the baseline values were between 7-20% (depends on the level of saturation).Spo2 was under alarm limit and was in silent mode.Due to the incorrect readings (a high downward deviation), an unnecessary arterial blood gas (abg) was performed.The second sensor was used for investigation but the issue also occurred.It was checked with two different saturation simulators which resulted that as lower the saturation was set, a higher was the deviation downwards.Third sensor was used and it worked effectively.

• 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: 20623182
• Report Number: 2936999-2024-01736
• Device Sequence Number: 12650547
• Product Code: DQA
• UDI-Device Identifier: 20884522041277
• UDI-Public: 20884522041277
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 11/06/2024

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 Expiration Date: 12/31/2024
• Device Model Number: MAX-I-I
• Device Catalogue Number: MAX-I-I
• Device Lot Number: 220170148H
• 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: 07/27/2023
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Prefer Not To Disclose