MalfunctionCGA
CARDIOCHEK PLUS ANALYZER
Received May 30, 2025 · Event occurred Apr 30, 2025
Report 1836135-2025-00007 · MDR key 22120065
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
Additional Manufacturer Narrative
CURRENTLY IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE MALFUNCTIONED, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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.
Description of Event or Problem
THERE WERE NO ALLEGATIONS OF PATIENT OR USER HARM. A PTS DIAGNOSTICS TECHNICAL SUPPORT SPECIALIST REPORTED THAT AN ANALYZER BECAME WARM TO THE TOUCH UPON BATTERY INSTALLATION. THIS REPORT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION.