MalfunctionFRI
LIVONGO SCALE
Received Jun 20, 2019 · Event occurred Jun 1, 2016
Report 3011196194-2019-00007 · MDR key 8718811
Device
Generic name
Scale
Manufacturer
Livongo Health, IncModel number
BT004LCatalog number
FG04087
Lot number
1905
Product problems
- Melted
- Melted
Patient
53 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. AFTER THE USER REPLACED THE BATTERIES THE BATTERY AREA BECAME HOT AND MELTED THE PLASTIC IN THE BATTERY COMPARTMENT AND ON THE BATTERY COMPARTMENT COVER. NO INJURY TO THE USER WAS REPORTED.