MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-18 for FITBIT ARIA SCALE FB201W manufactured by Fitbit.
[75768617]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069912 |
| MDR Report Key | 6581409 |
| Date Received | 2017-05-18 |
| Date of Report | 2017-05-18 |
| Date of Event | 2017-05-01 |
| Date Added to Maude | 2017-05-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FITBIT ARIA SCALE |
| Generic Name | FITBIT ARIA SCALE |
| Product Code | MNW |
| Date Received | 2017-05-18 |
| Model Number | FB201W |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FITBIT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-18 |