MAUDE Adverse Event Report: MMJ SA DE CV (USD) BIS; ELECTRODE, CUTANEOUS

Model Number 186-0200

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pressure Sores (2326)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, post operatively, the device was utilized during a liver transplant in a patient with hyperbilirubinemia.The surgery took 10 hours and 30 minutes of duration and after the end of surgery and device discarded, the medical team saw the skin injuries where device was placed.The skin injury included blisters on the skin in a circle format that was similar to the inside of the device's electrodes.After a week the patient does not have any problems in the location, the blisters on the skin disappeared.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted round spots corresponding to sensor positioning on the patient.It was reported that the patient's skin had an issue with the product that was placed in that area.The reported issue could not be 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.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: patient position may increase the risk of skin irritation on the forehead.With patients in prone position, consider minimizing pressure on the sensor.If skin rash or other unusual symptoms develop, stop use and remove.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: BIS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 11395290
• MDR Text Key: 234225711
• Report Number: 2936999-2021-00174
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 10884521134331
• UDI-Public: 10884521134331
• Combination Product (y/n): N
• PMA/PMN Number: K041670
• 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: 07/23/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 186-0200
• Device Catalogue Number: 186-0200
• Device Lot Number: 1231191L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 6 YR