LIVONGO SCALE
Received Sep 11, 2019 · Event occurred Aug 8, 2019
Report 3011196194-2019-00015 · MDR key 8994548
Device
Product problems
- Temperature Problem
- Temperature Problem
Patient
47 YR
- Patient Problem/Medical Problem
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
NO INJURY TO THE USER WAS REPORTED. THE SCALE WAS RETURNED TO THE MANUFACTURER, AND AN INVESTIGATION WAS PERFORMED. A PHYSICAL INSPECTION OF THE SCALE WAS PERFORMED AND FOUND A SMALL HOLE IN THE BACK OF THE SCALE. INITIAL FUNCTIONAL TESTING FOUND THAT THE SCALE DID NOT TURN ON. ROOT CAUSE WAS DETERMINED TO BE A USABILITY ISSUE, IN WHICH THE BATTERIES WERE INSERTED INTO THE SCALE INCORRECTLY, CAUSING A CAPACITOR TO SHORT CIRCUIT.
Description of Event or Problem
THE USER REPORTED THAT UPON BATTERY INSERTION THERE WAS A VISIBLE SPARK, AND A BURNING SMELL EMANATED FROM THE BATTERY COMPARTMENT. THE USER ALSO REPORTED THAT THE BATTERIES WERE WARM TO THE TOUCH AND A HOLE HAD MELTED IN THE BACK OF THE SCALE.