MAUDE Adverse Event Report: GE HEALTHCARE/ DATEX-OHMEDA, INC. GE HEALTHCARE AISYS CS2 ANESTHESIA MACHINE; GAS-MACHINE, ANESTHESIA

Model Number AISYS CS2

Device Problems Device Alarm System (1012); Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2020

Event Type  Injury  

Event Description

Anesthesiologist was not aware cartridge ejected causing inadequate flow of anesthesia, so patient had some awareness prior to issue being discovered.This is newer anesthesia machine and machine does not provide alarm or flashing lights or anything to alert that cartridge not securely locked in.Seems inserting cartridge requires more force and a double check to ensure it is locked in.

• Brand Name: GE HEALTHCARE AISYS CS2 ANESTHESIA MACHINE
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTHCARE/ DATEX-OHMEDA, INC. ; madison WI
• MDR Report Key: 10128322
• MDR Text Key: 194523081
• Report Number: MW5094874
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AISYS CS2
• Device Lot Number: 1011-9050-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2020
• 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): Other
• Patient Age: 25 YR