MAUDE Adverse Event Report: GE MEDICAL GE AISYS CS2; ANESTHESIA MACHINE: GAS MAHCINE ANESTHESIA

Model Number ALADIN 2 DES 1100-9026-000

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/02/2017

Event Type  malfunction  

Event Description

Pt awareness during surgical procedure while under anesthesia due to no agent in the vaporizer cassette.During the surgical procedure, the pt started to regain consciousness and moved.The unit started to alarm "check cassette" and the anesthesiologist noticed liquid desflurane leaking from the front of the vaporizer cassette.The leak allowed the entire volume of anesthetic agent to empty onto the machine.The anesthesiologist quickly tried to refill the cassette but liquid continued to leak all over.He then sedated the pt with an alternative drug and switch to the sevoflurane cassette.Procedure continued with no add'l issues.Prior to the case, the anesthesia tech performed a pre-use function and leak test, which passed without defecting any leaks.I contacted ge and they sent several engineers to investigate.We also contacted (b)(4) to investigate.It was determined by (b)(4) that the device(anesthesia machine) is unable to perform a valid leak test on the desflurane vaporizer cassette.It is however to perform leak tests on the sevo and isoflurane.After months of investigation, ge has no recommendations.Users have lost all confidence in the aisys cs2, due to the fact this has occurred on multiple occasions during ge's prolonged investigation.

• Brand Name: GE AISYS CS2
• Type of Device: ANESTHESIA MACHINE: GAS MAHCINE ANESTHESIA
• Manufacturer (Section D): GE MEDICAL; plano TX 75093
• MDR Report Key: 7330410
• MDR Text Key: 102315804
• Report Number: MW5075795
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALADIN 2 DES 1100-9026-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other