MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL, LLC RHYTHMLINK 3 ELECTRODE ARRAYS; ELECTRODE, CUTANEOUS

Model Number MRQD32415

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/23/2022

Event Type  malfunction  

Event Description

Patient was on long-term electroencephalogram (eeg) monitoring.Patient initially had a cap on for eeg and the cap was replaced two days later with a new cap.This cap was not staying on and was replaced after three days and replaced with the application of 32 electrodes (on for ten days).Skin prep was applied on skin prior to glue placement of the total of 32 eeg probes placed.After removing all 32 leads, it was found that there was a skin injury below one of the 32 probes.Currently there is no pressure on the skin.The wound was covered with mepilex and the wound & ostomy care team was notified to assess the patient's skin injury.During this entire timeframe, patient's head was being offloaded with z-flo pill and the patient was on a bed with low air loss mattress with a turn and position system.Description of skin impairment: unstageable skin injury located right posterior head.Full thickness tissue loss measures 0.6cm x 0.6cm x 0.1cm.Wound base is 70% dried, adherent eschar with 30% dry, tan tissue surrounding the eschar.Injury is consistent with the shape and size of an eeg electrode.Also considered that skin injury could be from glue (super adhesive), but unsure if an adhesive injury would give a deep injury.Facility is working on a procedure for long term eeg needs.

Event Description

Patient was on long-term electroencephalogram (eeg) monitoring.Patient initially had a cap on for eeg and the cap was replaced two days later with a new cap.This cap was not staying on and was replaced after three days and replaced with the application of 32 electrodes (on for ten days).Skin prep was applied on skin prior to glue placement of the total of 32 eeg probes placed.Eeg did not include the conductive cream that is squirted into the electrodes.After removing all 32 leads, it was found that there was a skin injury below one of the 32 probes.Currently there is no pressure on the skin.The wound was covered with mepilex and the wound & ostomy care team was notified to assess the patient's skin injury.During this entire timeframe, patient's head was being offloaded with z-flo pill and the patient was on a bed with low air loss mattress with a turn and position system.Description of skin impairment: unstageable skin injury located right posterior head.Full thickness tissue loss measures 0.6cm x 0.6cm x 0.1cm.Wound base is 70% dried, adherent eschar with 30% dry, tan tissue surrounding the eschar.Injury is consistent with the shape and size of an eeg electrode.Also considered that skin injury could be from glue (super adhesive), but unsure if an adhesive injury would give a deep injury.Facility is working on a procedure for long term eeg needs.

• Brand Name: RHYTHMLINK 3 ELECTRODE ARRAYS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): RHYTHMLINK INTERNATIONAL, LLC; 1140 first st. south; columbia SC 29209
• MDR Report Key: 14250135
• MDR Text Key: 290379790
• Report Number: 14250135
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2022,04/13/2022

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 Model Number: MRQD32415
• Device Lot Number: PM00021427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17520 DA
• Patient Sex: Male
• Patient Race: Black Or African American