MalfunctionFRI
LIVONGO SCALE
Received Oct 11, 2022 · Event occurred Sep 7, 2022
Report 3011196194-2022-00021 · MDR key 15584492
Device
Product problems
- Failure to Power Up
- Failure to Power Up
Patient
42 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
MEMBER REPORTS RECEIVING AN UNKNOWN ERROR MESSAGE ON MULTIPLE DAYS WHILE ATTEMPTING TO USE THEIR SCALE. MEMBER ALSO REPORTED THAT WHEN THEY OPENED THE BATTERY COMPARTMENT TO CHANGE THE BATTERIES, THERE WAS EVIDENCE OF BATTERY LEAKAGE. AFTER REMOVAL OF THE LEAKING BATTERIES, THE MEMBER REPLACED THEM WITH KNOWN GOOD BATTERIES AND THE SCALE WOULD THEN NOT TURN ON.
Additional Manufacturer Narrative
AS THE REPORTED ERROR MESSAGE IS UNKNOWN, WE ARE UNABLE TO DETERMINE ROOT CAUSE. MANUFACTURER BELIEVES THAT THE BATTERY LEAKAGE DAMAGED THE SCALE, CAUSING IT TO NOT POWER ON UPON REPLACEMENT OF BATTERIES.
Remedial action
- Replace