MalfunctionCGA
CARDIOCHEK PLUS ANALYZER
Received Nov 12, 2024 · Event occurred Oct 2, 2024
Report 1836135-2024-00040 · MDR key 20662256
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
Additional Manufacturer Narrative
CURRENTLY IT IS UNKNOWN WHETHER OR NOT 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.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEIR ANALYZER GETS HOT WHEN USING. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.