MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7900; ANESTHESIA GAS MACHINE

Model Number 1006-9305-000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Loss of consciousness (2418)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.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 the patient consciousness did not return post-procedure.Medical treatment was given.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and a review of the logs.The unit was found to be operating normally.Ge healthcare product engineering performed an investigation of this event.Analysis of the complaint and customer report found no evidence of a system malfunction.It has been confirmed that there was no direct allegation against the ge healthcare device.Based on the investigation analysis, there is no evidence of a malfunction or defect of this unit and no evidence that the device contributed to the patient's not regaining consciousness.Therefore, no additional corrective or preventive actions are planned.The root cause is undetermined.

• Brand Name: AESTIVA 7900
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8726376
• MDR Text Key: 148920670
• Report Number: 2112667-2019-00187
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K023366
• 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: 08/27/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 1006-9305-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other