MAUDE Adverse Event Report: DATEX-OHMEDA, INC. GENERAL ELECTRIC AVANCE CS2 ANESTHESIA MACHINE AVANCE CS2; GAS-MACHINE, ANESTHESIA

Model Number AVANCE CS2

Device Problems Product Quality Problem (1506); Defective Device (2588); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 07/30/2021

Event Type  Injury  

Event Description

The ge advance cs2 anesthesia machine failed to detect a 10 liter/min fresh gas flow leak during it's set up procedures (the full leak-test procedure the manufacturer set as required on initiation of the machine's use).This is the second time this model (different machine) has done this: failed to detect a 10 lpm flow leak during it's full leak-test.This is absolutely unacceptable and i have never seen such poor qi/qa on the part of an anesthesia machine manufacturer in my 19 years of anesthesia practice (i am an anesthesiologist).Fda safety report id# (b)(4).

• Brand Name: GENERAL ELECTRIC AVANCE CS2 ANESTHESIA MACHINE AVANCE CS2
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DATEX-OHMEDA, INC.
• MDR Report Key: 12275732
• MDR Text Key: 265179514
• Report Number: MW5102968
• Device Sequence Number: 1
• Product Code: BSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVANCE CS2
• Is the Reporter a Health Professional?: 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
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 45 YR