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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/16/2022

Event Type  Injury  

Event Description

The hospital reported a patient was connected to an aestiva mri during a magnetic resonance exam when the patient desaturated followed, reportedly, by a lower heart rate.The patient was switched to manual ventilation using an ambu bag.Cpr was performed until the patient was stabilized and was under observation in the hospitals icu.The patient's current clinical condition was not reported.Ge healthcare will submit a follow-up report when the investigation has been completed.

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.Information not provided.Legal manufacturer: (b)(4).Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

The ge field engineer inspected the aestiva mri, and no issues were identified.The aestiva mri delivered the set pressures after switching ventilation modes.This indicates that a patient circuit leak likely contributed to the loss of ventilation and that the leak was resolved when mechanical ventilation was resumed from the aestiva mri, and/or there was an issue ventilating the patient that was resolved by the aspiration maneuver.The root cause of the loss of ventilation is undetermined; there is no evidence of any electrical or mechanical errors that contributed to the loss of ventilation in volume-controlled mechanical ventilation.

• 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: 14112632
• MDR Text Key: 289276706
• Report Number: 2112667-2022-00867
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 06/03/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2008
• 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 Weight: 13 KG