MAUDE Adverse Event Report: ACTIGRAPH, LLC ACTIGRAPH CENTREPOINT INSIGHT WATCH; DEVICE, SLEEP ASSESSMENT

Model Number	CPW01
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	09/28/2021
Event or Problem Description
A customer (research coordinator) informed actigraph that a participant reported feeling a "shock" while wearing the wrist-worn device on (b)(6) 2021.The participant described walking from one room in their home to another area when they received an unexplained "shock running from the wrist to the elbow." the participant removed the device for the remainder of the day, but they chose to wear the device the next day.At the time of this event, the participant had been wearing the device for approximately 5 months, for 20+ hours of wear time per day, with no prior issues.The participant did not seek in-person medical care at the time of this report, and the clinical site will continue to monitor and investigate this event.Actigraph has deployed wearable activity monitors for over 15 years with no prior reports of this nature.This device design is tested for electrical safety (iec 60601) via a qualified third-party vendor.The device utilizes a low power rechargeable battery (4.2v) equipped with a safety circuit to prevent discharge occurrence.The device will be evaluated to complete the investigation.Fda safety report id# (b)(4).

• Brand Name: ACTIGRAPH CENTREPOINT INSIGHT WATCH
• Common Device Name: DEVICE, SLEEP ASSESSMENT
• Manufacturer (Section D): ACTIGRAPH, LLC
• MDR Report Key: 12719412
• Report Number: MW5105016
• Device Sequence Number: 11129532
• Product Code: LEL
• UDI-Device Identifier: 00853048008039
• UDI-Public: (01)00853048008039
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

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?: No
• Operator of Device: Other
• Device Model Number: CPW01
• Device Lot Number: 9958
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1