MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; OXIMETER

Model Number	FLEXMAX
Medical Device Problem Codes	Low Readings (2460); Delayed Program or Algorithm Execution (4034)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
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, during use, the sensor had a reading even when not on the patient.The patient with a tracheostomy and a high risk of decannulation was having spo2 monitored using the ear clip sensor.The nurse noted that the spo2 was low at 86% as they walked past the bed space and then noticed that the sensor was on the pillow next to the patient's cheek but was still showing a trace and spo2 of 86%.Later that day, the ear clip sensor was found in the patient's hand, and it was still picking up a trace and a reading.There was no patient injury.
Additional Manufacturer Narrative
New information has been received pertaining to the event.This event has been reassessed and it was determined that medtronic is not responsible for the regulatory report.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, during use, the sensor was taken off from the patient finger, held it in hand and it was picking up a reading which should not be.Upon testing in the hospital the sensor still pick up reading even not on finger.There was no patient injury.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer (Section G): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20256929
• Report Number: 1282497-2024-00396
• Device Sequence Number: 20724018
• Product Code: DQA
• UDI-Device Identifier: 10884521532304
• UDI-Public: 10884521532304
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162014
• 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): 09/24/2024

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 Model Number: FLEXMAX
• Device Catalogue Number: FLEXMAX
• Device Lot Number: JBL10099
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 09/24/2024
• Date Device Manufactured: 01/02/2024
• 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: Unknown