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

Model Number MAXA

Device Problems Incorrect Measurement (1383); Failure to Analyze Signal (1539); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the sensor had no spo2 readings or signal acquisition.When used on a patient, a reading of 100% was coming and going and it had a noticeable interference in trace.A wrap was used to secure it on patient's finger and site was checked every 4 hours.The same sensor was plugged in a different monitor and got solid reading of 90%, however waveform was not very clean.Another sensor was plugged into different module and had same result as before of noisy trace and intermittent incorrect reading.The module was removed from the main monitor and plugged into a portable monitor running in battery with same result.The reported sensor was covered with towel and the waveform improved and correct spo2 reading was obtained.The towel covering the sensor was then removed and waveform had good quality.There was no patient injury.

Manufacturer Narrative

Additional information: b5, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.However, a video was provided.Visual inspection noted that the oxygen saturation (spo2) fluctuated and the waveforms were irregular.It was reported that the monitor provided incorrect readings but it was not stated if the readings were too high or low.The product also did not send communications.The reported issues were 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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the sensor had no spo2 readings or signal acquisition.When used on a patient, a reading of 100% was coming and going and it had a noticeable interference in trace.A wrap was used to secure it on patient's finger and site was checked every 4 hours.The same sensor was plugged in a different monitor and got solid reading of 90%, however waveform was not very clean.Another sensor was plugged into different module and had same result as before of noisy trace and intermittent incorrect reading.The module was removed from the main monitor and plugged into a portable monitor running in battery with same result.The reported sensor was covered with towel and the waveform improved and correct spo2 reading was obtained.The towel covering the sensor was then removed and waveform had good quality.There was no patient injury.It was reported that, it was not isolated to maxa, this is an ongoing related to all sensors used in the unit and being affected by led lighting, the lighting is a smart lighting system, dali.The values that were observed showing value of 100% which was incorrect when sensor exposed to the led lights.Showed 91% when sensor covered.The user set a baseline prior to the start of the procedure at 9% values when incident occurred.

• Brand Name: NELLCOR
• Type of Device: 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: 18239154
• MDR Text Key: 329478271
• Report Number: 1282497-2023-00065
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10817357020011
• UDI-Public: 10817357020011
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K012891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAXA
• Device Catalogue Number: MAXA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1