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U.S. Department of Health and Human Services

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

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ACTIGRAPH, LLC ACTIGRAPH CENTREPOINT INSIGHT WATCH DEVICE, SLEEP ASSESSMENT Back to Search Results
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).
 
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Brand NameACTIGRAPH CENTREPOINT INSIGHT WATCH
Type of DeviceDEVICE, SLEEP ASSESSMENT
Manufacturer (Section D)
ACTIGRAPH, LLC
MDR Report Key12719412
MDR Text Key279812025
Report NumberMW5105016
Device Sequence Number1
Product Code LEL
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberCPW01
Device Lot Number9958
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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