MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RED DOT¿ MONITORING ELECTRODES; ECG ELECTRODE

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problem Death (1802)

Event Date 11/11/2018

Event Type  Death  

Manufacturer Narrative

Information was not provided.Actual device used in this report was not available for analysis.Customer provided lot number 2020 10 fh which was found in the unit.It was unknown if this was the same lot number of the electrodes used in this event.Customer stated samples from the same stock would be sent to 3m for analysis.Samples have not been received to date.Concomitant medical products: phillips heart start mrx defibrillator lead wires.3m received information from two reporters at the facility.Information from both reporters was provided in this report.Medwatch (b)(4) was received on 11dec2018 from the fda.Although the facility reported there was no association or findings that the patient death was related to the incident in this complaint, 3m is submitting this mdr report because a patient death reportedly occurred.Retained samples of the electrodes from this lot number were tested and met specifications.End of report.

Event Description

A nurse reported a patient in icu experienced a slight delay with an urgent cardioversion when 2670-5 red dot electrode stubs were found stuck in the defibrillator lead wires from a previous use.The slight delay occurred when the staff obtained another defibrillator from the unit for the cardioversion.The patient in this report later expired.No information was provided related to the patient's medical condition/diagnosis, time of the incident or time of the patient death.The nurse reported there was no association or findings that the patient death was related to this event.

• Brand Name: 3M¿ RED DOT¿ MONITORING ELECTRODES
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M CANADA COMPANY; 400 route 100; morden, R6M 1 Z9; CA R6M 1Z9
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 8160628
• MDR Text Key: 130222189
• Report Number: 2110898-2018-00112
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10707387499966
• UDI-Public: 10707387499966
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2020
• Device Model Number: N/A
• Device Catalogue Number: 2670-5
• Device Lot Number: 2020 10 FH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2018
• 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
• Treatment: LEAD WIRES
• Patient Outcome(s): Death
• Patient Age: 80 YR