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

Model Number	D-YS
Medical Device Problem Codes	Failure to Read Input Signal (1581); Low Readings (2460); Delayed Program or Algorithm Execution (4034)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
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.It was tested on a handheld monitor; the sensor was clipped to receive a reading, then held hand over the sensor to see if a reading was picked up.As soon as the sensor was removed, the reading dropped off.However, when rubbing the peripheral part of the sensor, there was a slight quick reading, which should not happen.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
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that during use, the sensor had a reading even when not on the patient.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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
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.

• 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: 20199147
• Report Number: 1282497-2024-00381
• Device Sequence Number: 12450125
• Product Code: DQA
• UDI-Device Identifier: 20884522042540
• UDI-Public: 20884522042540
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K012891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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 Model Number: D-YS
• Device Catalogue Number: D-YS
• Device Lot Number: 240020038H
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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