MAUDE Adverse Event Report: FITBIT FITBIT ARIA SCALE

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.

• Brand Name: FITBIT ARIA SCALE
• Type of Device: FITBIT ARIA SCALE
• Manufacturer (Section D): FITBIT
• MDR Report Key: 6581409
• MDR Text Key: 75768617
• Report Number: MW5069912
• Device Sequence Number: 1
• Product Code: MNW
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FB201W
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 95