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

Model Number 1006-9310-000

Device Problem Infusion or Flow Problem (2964)

Patient Problem Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 02/20/2024

Event Type  Injury  

Manufacturer Narrative

Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.

Event Description

The hospital reported a patient was connected to an aestiva mri in the mri suite when it was alleged that the patient reported being awake during the procedure.Reportedly, it was noted that the amount of agent used during the procedure was less than expected for the length of the procedure.The patient reported being psychologically affected.Ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

The ge healthcare field engineer (fe) and hospital biomed specialist found no entries on the devices alarm logs.They performed a leak test and verified the output of sevoflurane from the tec 7 vaporizer.Both tests passed, and the fe reported being unable to reproduce the insufficient agent delivery.The device was then returned to service.It is unclear how the patient was ventilated during an mri procedure, which is not directly attended, and attempts to get further information were unsuccessful.Therefore, the contributing factors must then be attributed to either use error or a breathing circuit leak within the patient circuit.The root cause of the patient experiencing awareness is undetermined as there is no evidence of a device malfunction.Block d4: no udi as the device was manufactured prior to udi compliance requirements.

• Brand Name: AESTIVA MRI
• 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: 19018711
• MDR Text Key: 339100312
• Report Number: 2112667-2024-01754
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/02/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1006-9310-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2001
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 97 KG