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

Device Problem Infusion or Flow Problem (2964)

Patient Problems Awareness during Anaesthesia (1707); Eye Injury (1845)

Event Date 12/10/2018

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.Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that, during a vitrectomy procedure, the patient moved, resulting in bleeding in the patient's eye.

Manufacturer Narrative

Ge healthcare product engineering performed an investigation into the reported occurrence.A review of the logs showed that the system performed as designed during this event.Per the investigation, this patient case was unique in that the clinician had to balance the level of anesthesia to control the patientâ¿¿s pain and suppress movement against too much sevoflurane anesthetic agent adversely affecting the patientâ¿¿s cardiovascular system.The system logs and breath trend show no report of any anesthesia system malfunction, or ventilator or gas delivery malfunctions, or et (end-tidal) control malfunction.The root cause of this event was determined to be user error.

• 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: 8216966
• MDR Text Key: 132059420
• Report Number: 2112667-2019-00006
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention