MalfunctionCBQ

A5 ANESTHESIA DELIVERY SYSTEM

Received Jan 12, 2015 · Event occurred Nov 21, 2014

Report 2221819-2014-01123 · MDR key 4479803

Device

Generic name

Anesthesia Delivery System

Manufacturer

Mindray Bio-medical Electronics Co. Ltd.

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 A5 ANESTHESIA DELIVERY SYSTEM DISPLAY, WHICH MAY HAVE AFFECTED ANESTHESIA MONITORING. NO PATIENT MONITORING WAS REPORTED.

Additional Manufacturer Narrative

COMPANY REPRESENTATIVE EVALUATED THE SYSTEM. CORRECTIONS INCLUDED REPLACEMENT OF THE SYSTEM'S CPU BOARD, RELOADING SYSTEM'S SOFTWARE, AND CALIBRATING. SYSTEM WAS TESTED TO FACTORY'S SPECIFICATIONS.