CARDIOCHEK PLUS ANALYZER
Received Apr 3, 2025 · Event occurred Feb 15, 2025
Report 1836135-2025-00005 · MDR key 21762745
Device
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM OR INCORRECT RESULTS. THE CUSTOMER REPORTED THAT THEIR ANALYZER " STARTED GETTING VERY WARM AND SMOKING AND EVENTUALLY BATTERIES EXPLODED INSIDE ANALYZER". THE REPORTED ANALYZER WAS BEING USED OUTSIDE IT'S RECOMMENDED DEVICE LIFE OF 3 YEARS (APPROXIMATELY 7 YEARS OLD).
Additional Manufacturer Narrative
CURRENTLY IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE MALFUNCTIONED, AS THE ANALYZER WAS NOT RETURNED. IT IS KNOWN THAT IMPROPER INSERTION OF BATTERIES- IN ANY DEVICE- MAY RESULT IN OVERHEATING, BATTERY LEAKAGE, ETC., WHICH IS STATED IN THE LABELING OF MOST BATTERY MANUFACTURERS.