MalfunctionCGA
CARDIOCHEK PLUS ANALYZER
Received Jan 9, 2025 · Event occurred Dec 23, 2024
Report 1836135-2025-00001 · MDR key 21117935
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Pts DiagnosticsProduct 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
THE CUSTOMER REPORTED THAT, WHEN BATTERIES ARE INSERTED, "IT BEGINS HEATING UP" AND "GETS SUPER HOT QUICKLY". THERE WAS NO ALLEGATION OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.
Additional Manufacturer Narrative
CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE MALFUNCTIONED, AS THE DEVICE 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.