MAUDE Adverse Event Report: 3M HEALTH CARE 3M RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL; ECG ELECTRODE

Model Number N/A

Device Problem Missing Value Reason (3192)

Patient Problems Death (1802); Sudden Cardiac Death (2510); Patient Problem/Medical Problem (2688)

Event Date 06/09/2017

Event Type  Death  

Manufacturer Narrative

No patient information was provided.The biomed initially reported the event.On (b)(4) 2017 3m obtained additional information from a nurse (health professional) regarding the reported event.Our technical representative believes the new philips leadwires (including model m1673a) are more aggressive than other leadwires.This can create an issue with electrodes having plastic studs/snaps as in this case.This is not an issue with electrodes having metal studs/snaps.End of report.

Event Description

A biomedical engineer reported that 3m red dot¿ monitoring electrode with foam tape and sticky gel were adhered to a patient who was coding.Another manufacturers leadwires were attached to the 3m electrodes.The patient was defibrillated.The leads were removed.Allegedly the plastic snap from each electrode was pulled off with the leadwires.The hospital staff did not attempt to apply other electrodes to the patient because the patient died.Additional information received 30jun17 - a nurse provided information that the 3m electrodes were applied to a patient who was coding.Leadwires were attached to the electrodes.The electrodes or leadwires became wet.While replacing the electrodes, the leadwires pulled the snaps from the electrodes.The staff obtained a different monitor but found there were electrode snaps in the leadwires from a previous case.The staff obtained another monitor but the patient died.(current information concerning the initial reported event).

• Brand Name: 3M RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL
• 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; R6M 1 Z9; CA R6M 1Z9
• Manufacturer Contact: linda johnsen ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517374376
• MDR Report Key: 6695076
• MDR Text Key: 79327627
• Report Number: 2110898-2017-00093
• Device Sequence Number: 1
• Product Code: DRX
• 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,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 2570
• Device Lot Number: 2018-11 EL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2016
• 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: DEFIBRILLATOR (TYPE NOT SPECIFIED); MONITOR (TYPE NOT SPECIFIED); PHILIPS LEADWIRES MODEL M1673A
• Patient Outcome(s): Death