CARDIOCHEK PLUS ANALYZER
Received Oct 22, 2025 · Event occurred Sep 21, 2025
Report 1836135-2025-00016 · MDR key 23363720
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
THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. . 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 (OR 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
THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM OR INACCURATE RESULTS. THE CUSTOMER REPORTED THAT "TWO BATTERIES WERE MELTED TOGETHER AND THEY WERE WARM." CONTACT CONFIRMED THERE WAS NO FLAME/FIRE.