MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL, LLC RHYTHMLINK®; ELECTRODE, CUTANEOUS

Model Number	DC2415
Health Effect - Clinical Codes	Skin Discoloration (2074); Pressure Sore/Ulcer (2326)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient seen in skin response for potential pressure injuries to the forehead.Electrodes were placed for eeg [electroencephalogram] study from [redacted] to [redacted] - three days long.On [redacted] - the last day, electrodes were removed and 3 distinct purple areas that align with the shape of electrodes.These areas were identified and brought to our attention by unit skin champions.Areas have evolved from 3 separate areas of purple discoloration to 3 areas of eschar which are well adhered.Given the characteristics of the wounds, they are now 3 unstageable pressure injuries (left, middle, and right forehead).The information provided for the device is from another similar device as the device involved in the event was discarded by staff.

• Brand Name: RHYTHMLINK®
• Common Device Name: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): RHYTHMLINK INTERNATIONAL, LLC; 1140 first st. south; columbia SC 29209
• MDR Report Key: 23735745
• Report Number: 23735745
• Device Sequence Number: 8460391
• Product Code: GXY
• UDI-Device Identifier: 10816312023654
• UDI-Public: (01)10816312023654
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2025
• Report Date (Section F): 11/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DC2415
• Device Catalogue Number: DC2415
• Device Lot Number: PM00039823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Date Report Sent to FDA: 11/24/2025