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

Device Problem Infusion or Flow Problem (2964)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 03/21/2022

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.(b)(4).Legal manufacturer: hcs madison - (b)(4).Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported a patient experienced awareness while under anesthesia during a left mastectomy and axillary clearance.The patient was given propofol, midazolam, and sevoflurane.The hospital reports that after the event, the patient is in good health and there are no further reports of distress from awareness.The patient was offered and accepted a psychologist referral.Ge healthcare's investigation into the reported occurrence is ongoing.

Manufacturer Narrative

The o2 concentration, total flow, and anesthetic agent settings in use during the case are unknown, and the customer does not report evidence (e.G.Device alarms or bis entropy values) from during the procedure that there was insufficient anesthetic agent being delivered.This device was used for cases both before and after this event with no reported issues regarding light anesthesia.Therefore, the root cause of the patient awareness reported after the case cannot be determined, though the leak in the o2 flowtube due to a missing part after repair by a non-ge hospital engineer is a potential contributor.The hospital engineer did not perform post-service checkout as instructed by the technical reference manual and the user did not perform pre-use checkout, which would have alerted the user to a leak prior to patient use.

• Brand Name: AESPIRE VIEW
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 14249891
• MDR Text Key: 290372699
• Report Number: 2112667-2022-01082
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 73 KG