MalfunctionFRI
LIVONGO SCALE
Received Jun 20, 2019 · Event occurred May 6, 2019
Report 3011196194-2019-00008 · MDR key 8719071
Device
Generic name
Scale
Manufacturer
Livongo Health, Inc.Model number
BT004LCatalog number
FG04087
Lot number
1905
Product problems
- Temperature Problem
- Temperature Problem
Patient
68 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE SCALE WAS REQUESTED FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION. NO INJURY TO THE USER WAS REPORTED. AN INVESTIGATION WILL BE CONDUCTED BUT HAS NOT YET BEGUN. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
THE USER REPORTED THAT THE SCALE WOULD NOT TURN ON. THE USER REINSERTED THE BATTERIES AND SAID "THE BATTERY COMPARTMENT WAS GETTING WARM". NO INJURY TO THE USER WAS REPORTED.