MAUDE Adverse Event Report: GE HEALTH CARE ANESTHESIA MACHINE`; GAS-MACHINE, ANESTHESIA

Model Number AVANCE CS 2 PRO

Device Problem Device Sensing Problem (2917)

Patient Problem Insufficient Information (4580)

Event Date 08/31/2021

Event Type  malfunction  

Event Description

The ge advance cs 2 pro anesthesia machine displayed alarm "cannot read gas supply pressures" during surgery and stopped ventilating the pt.

• Brand Name: ANESTHESIA MACHINE`
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTH CARE; WI
• MDR Report Key: 12432567
• MDR Text Key: 270503162
• Report Number: MW5103725
• Device Sequence Number: 1
• Product Code: BSZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVANCE CS 2 PRO
• Device Catalogue Number: 1009-9050-000
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1