inforMED
MalfunctionBZK

GAS MODULE

Received May 29, 2015 · Event occurred Mar 24, 2015

Report 2221819-2015-00233 · MDR key 4810958

Device

Generic name

Gas Module

Product problems

  • Device Operates Differently Than Expected

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

CUSTOMER REPORTED AN ISSUE WITH THE GAS MODULE WHICH MAY HAVE AFFECTED PATIENT MONITORING. NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

THE DEVICE WAS EVALUATED. CORRECTIONS INCLUDED CALIBRATING THE GAS MODULE. PERFORMANCE TESTED TO FACTORY SPECIFICATIONS.