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

Model Number CPW01

Device Problem Output Problem (3005)

Patient Problem Electric Shock (2554)

Event Date 09/28/2021

Event Type  No Answer Provided  

Event 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
• Type of Device: DEVICE, SLEEP ASSESSMENT
• Manufacturer (Section D): ACTIGRAPH, LLC
• MDR Report Key: 12719412
• MDR Text Key: 279812025
• Report Number: MW5105016
• Device Sequence Number: 1
• Product Code: LEL
• UDI-Device Identifier: 00853048008039
• UDI-Public: (01)00853048008039
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Model Number: CPW01
• Device Lot Number: 9958
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1