MalfunctionECX

CRYO TANK

Received Nov 9, 2021 · Event occurred Oct 14, 2021

Report 12778516 · MDR key 12778516

Device

Generic name

Cryo Tank

Manufacturer

Praxair Distribution, Inc.

Product problems

Gas Output Problem
Manufacturing, Packaging or Shipping Problem
Therapeutic or Diagnostic Output Failure

Patient

Unknown

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

AFTER CHANGING OUT THE CRYO TANK, THE CRYOABLATION MACHINE STOPPED WORKING. IT WAS FOUND THAT NITRIC OXIDE TANK CONTAINS THE WRONG GAS. THE CYRO TANK SHOULD HAVE NON-MEDICAL GRADE AIR. IT CONTAINED MEDICAL GRADE NITRIC OXIDE, WHICH IS USED BY ANESTHESIA. BOTH TANKS WERE APPROPRIATELY LABELED AND ARE SPECIFIC TO THE CRYOABLATION CONSOLE. THIS INCORRECT GAS CAUSED THE CONSOLE TO MALFUNCTION. ONCE THE CORRECT GAS FROM ANOTHER TANK WAS HOOKED UP AND TESTED, THE MACHINE WORKED FINE.