inforMED
InjuryMRR

PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER

Received Dec 17, 2018 · Event occurred Dec 12, 2018

Report MW5082217 · MDR key 8175532

Device

Generic name

System, Test, Low Density, Lipoprotein

Product problems

  • Burst Container or Vessel
  • Melted
  • Loss of Power
  • Temperature Problem

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

DEVICE: CARDIOCHEK PLUS ANALYZER MACHINE WAS TURNED ON FOR BRIEF PERIOD (10 MINUTES OR LESS) AND THEN TURNED OFF. THIS WAS DURING A TRAINING, SO NO PATIENT WAS HARMED. WHILE MACHINE WAS TURNED OFF, IT BEGAN HEATING UP AND BECAME HOT TO THE TOUCH. THE BATTERY COVER WAS OPENED (4 AA BATTERIES ARE USED) AND THE BATTERIES WERE MELTING AND BECAME MOLTEN. THE EMPLOYEE WAS ABLE TO REMOVE THE BATTERIES WITHOUT INJURY, BUT AFTERWARDS THE AA BATTERIES EXPLODED. THIS IS OUR THIRD DEVICE TO OVERHEAT IN 2018, BUT FIRST TIME THAT THE BATTERIES HAVE BECOME MOLTEN AND EXPLODED.