CARDIOCHEK PLUS ANALYZER
Received Aug 23, 2024 · Event occurred Jul 22, 2024
Report 1836135-2024-00031 · MDR key 20053917
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
THIS IS A FOLLOW-UP SUBMISSION AS THE CUSTOMER ANALYZER WAS RETURNED. SLIGHT CORROSION WAS OBSERVED IN THE BATTERY COMPARTMENT BUT WOULD NOT ALIGN WITH THE DESCRIPTION OF THE EVENT BY THE CUSTOMER AS AN "EXPLOSION." THE RETURNED ANALYZER DID NOT OVERHEAT AT ANY POINT DURING THE INVESTIGATION. 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 CARDIOCHEK PLUS ANALYZER "BEGAN TO OVERHEAT AND THE BATTERY EXPLODED." THERE WERE NO ALLEGATIONS 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 HAS NOT YET BEEN 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 CARDIOCHEK PLUS ANALYZER "BEGAN TO OVERHEAT AND THE BATTERY EXPLODED." THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.