CARDIOCHEK PLUS ANALYZER
Received Feb 12, 2025 · Event occurred Jan 2, 2025
Report 1836135-2025-00002 · MDR key 21361758
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Pts DiagnosticsModel number
1.11Catalog number
2700
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
UPON VISUAL INSPECTION OF THE BATTERY COMPARTMENT, PLASTIC CASE DAMAGE INDICATIVE OF IMPROPER/FORCEFUL REMOVAL OF THE BATTERIES WITH A FOREIGN OBJECT WAS OBSERVED. PTS IS CONFIDENT THAT THIS DAMAGE OCCURRED POST-DISTRIBUTION, AS THERE ARE NO MANUFACTURING STEPS THAT WOULD CAUSE THIS TYPE OF DAMAGE. THE CUSTOMER ALLEGATION OF OVERHEATING WAS OBSERVED NOT OBSERVED ON THE RETURNED ANALYZER. NUMEROUS BATTERY COMPARTMENT IMPROVEMENTS HAVE ALREADY BEEN IMPLEMENTED PRIOR TO THESE ALLEGATIONS FROM THE FIELD. PROCESS IMPROVEMENTS AND PART SPECIFICATIONS HAVE ENHANCED SEATING AND HOLD CAPACITY OF THE BATTERY CONTACTS. ADDITIONALLY, A NEW BATTERY COMPARTMENT DESIGN (APPROVED BY THE FDA PER K193406) ELIMINATES THE POTENTIAL FOR OVERHEATING BY REMOVING THE POINT OF CONTACT THAT AN UNSEATED TERMINAL WOULD REACH.
Description of Event or Problem
THE CUSTOMER REPORTED THAT "BATTERIES WERE HEATING UP AND THEY COULD FEEL THE COMPARTMENT WAS WARM AND SMELLED A FAINT BURNING." THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS. THIS REPORT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION.