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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 09/28/2015

Event Type  Injury  

Manufacturer Narrative

Ge healthcare¿s investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

Following the case, the patient reported having recall of the surgical procedure.The patient will reportedly require psychological treatment as a result.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment and found it to function within manufacturer¿s specifications.The logs were downloaded and forwarded to the manufacturing site for investigation.The log review indicates that the reservoir of liquid anesthetic agent contained in the vaporizer cassette being used to provide anesthesia to the patient was consumed to the point of reading ¿empty¿ during agent delivery.The cassette remained empty for just over 2 hours until it was replaced with another cassette.The logs confirm the user was interacting with the aisys device and, thus, in a position to observe the displayed information regarding inhaled agent concentration and cassette agent level being empty and requiring refilling.The root cause of the reported complaint was due to a use error in failing to react to the multiple indications that the agent cassette had run dry of anesthetic agent leading to light anesthesia.

• Brand Name: AISYS
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; 540 w. northwest highway; barrington, IL 60010-3076
• MDR Report Key: 5165664
• MDR Text Key: 28839904
• Report Number: 2112667-2015-00176
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• 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: 56 YR
• Patient Weight: 101