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

Model Number 1011-9050-000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 05/24/2020

Event Type  Injury  

Manufacturer Narrative

Ge healthcareâs investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Unique identifier: (b)(4).

Event Description

The hospital reported that during a procedure, there was inadequate flow of anesthesia caused by an ejected anesthetic agent cartridge, resulting in patient awareness and recall.The cartridge was replaced and case resumed.No report of patient injury.

Manufacturer Narrative

This supplemental correction filed to note that the initial mdr was to have been reported as a serious injury due to patient awareness and recall.Block b1, b2, and h1 updated accordingly.Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.

Manufacturer Narrative

There was no ge employee visit to this site, and therefore the repair is unknown.Ge healthcare product engineering performed an investigation of this event.Neither the cassette or vaporizer bay from the complaint were returned to ge healthcare (gehc) for testing.After testing with several available cassettes in the lab, engineering has not been able to reproduce a situation in which a cassette would be able to deliver agent and eject from the vaporizer bay without a user releasing the latch.The allegation that the machine did not alarm is unsubstantiated without device logs.The hospital risk manager gave the following statements: 1."the aisys cs2 is a new device and the staff are not familiar with it, as it is different than other devices used." 2."the event was caused by human error and the vendor came to re-educate staff and train new employees." 3."the user felt that the alarm was not prevalent and should be higher priority." removing the cassette during the case is expected in situations where agent runs low or to change agent types, so a higher priority alarm is considered to be a nuisance when the clinician is swapping cassettes.The patient said they were able to recall pain but denied any nightmares or trauma.The patient declined psychological evaluation and treatment.The root cause for this event is undetermined based on the available information.H3 other text : there was no ge employee visit to this site, and therefore the repair is unknown.Ge healthcare product engineering performed an investigation of this event.Neither the cassette or vaporizer bay from the complaint were returned to ge healthcare (gehc) for testing.After testing with several available cassettes in the lab, engineering has not been able to reproduce a situation in which a cassette would be able to deliver agent and eject from the vaporizer bay without a user releasing the latch.The allegation that the machine did not alarm is unsubstantiated without device logs.The hospital risk manager gave the following statements: 1."the aisys cs2 is a new device and the staff are not familiar with it, as it is different than other devices used." 2."the event was caused by human error and the vendor came to re-educate staff and train new employees." 3."the user felt that the alarm was not prevalent and should be higher priority." removing the cassette during the case is expected in situations where agent runs low or to change agent types, so a higher priority alarm is considered to be a nuisance when the clinician is swapping cassettes.The patient said they were able to recall pain but denied any nightmares or trauma.The patient declined psychological evaluation and treatment.The root cause for this event is undetermined based on the available information.

• Brand Name: AISYS CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 10340683
• MDR Text Key: 201890743
• Report Number: 2112667-2020-02125
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K132530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1011-9050-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Weight: 88