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

Model Number MAX-N-I

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the device caused skin integrity issue.The patients had a second degree burn and they had to apply comfeel and bepanthen to balm the redness.

Manufacturer Narrative

Additional information: d4 (expiration date and lot#).H3 evaluation summary: medtronic conducted an investigation based upon all information received.Eighty max-n-i devices were received for evaluation.One of the max-n-i sensors was used and the other seventy-nine were new and unused.The returned used sensor and a sample of five randomly unused returned sensors were selected for testing.Visual inspection noted no notable conditions.Functional testing noted that the sensors emitted a visible light, which was confirmed by shining the light on the tester¿s index finger.When the sensors were wrapped around the tester¿s finger, it successfully detected the oxygen saturation and cardiac-induced pulse readings.The sensors were then tested and was found to function within specifications.It was reported that the device caused skin integrity issue.An associated device issue could not be confirmed.The most likely root cause could not be identified because no related problem was detected with the device.The evaluation found no potentially contributing factors, and the sample met all related specifications.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: "if the sensor is misapplied with excessive pressure for prolonged periods, a pressure injury can occur." 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.

• Brand Name: NELLCOR
• Type of Device: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 9732240
• MDR Text Key: 180214892
• Report Number: 2936999-2020-00146
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 20884522040379
• UDI-Public: 20884522040379
• Combination Product (y/n): N
• PMA/PMN Number: K012891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: MAX-N-I
• Device Catalogue Number: MAX-N-I
• Device Lot Number: 193010048H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1