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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FITBIT FITBIT ARIA SCALE

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FITBIT FITBIT ARIA SCALE Back to Search Results
Model Number FB201W
Device Problems Premature Discharge of Battery (1057); Self-Activation or Keying (1557); Temperature Problem (3022)
Patient Problem No Information (3190)
Event Date 05/01/2017
Event Type  malfunction  
Event Description
For several months, the (b)(6) area scale has been persistently draining batteries via uncontrollable self-activation. This happens regardless of whether the batteries are removed and reinstalled, or completely replaced. Lately, replacing or reinstalling the batteries has put the scale in a perpetual "setup active" cycle, rendering it effectively useless. There are numerous reports on the (b)(6) community website of similar issues, reported by other owners. (b)(6) has not pushed any sort of software patch out to fix the issue, and refuses to issue a recall to replace the affected products. With constant activation, the device and batteries reach higher temperature than is probably expected under normal use.
 
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Brand NameFITBIT ARIA SCALE
Type of DeviceFITBIT ARIA SCALE
Manufacturer (Section D)
FITBIT
MDR Report Key6581409
MDR Text Key75768617
Report NumberMW5069912
Device Sequence Number1
Product Code MNW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFB201W
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

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