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 Cardiac Arrest (1762)

Event Date 07/18/2022

Event Type  malfunction  

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.No patient information provided.Legal manufacturer: (b)(4).Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported patient cardiorespiratory arrest during use of the aespire 7900.The patient was resuscitated with an ambu (artificial manual respiration unit) bag until the condition was reversed.Ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

It is determined that the aespire mri did not cause or contribute to the adverse event.The customer wanted the equipment evaluated to be certain that it did not influence the event.The customer confirmed through follow-up communication that the device did not stop ventilating at any time, and there was no malfunction or loss of ventilation.Inspection by a ge field engineer found no source of malfunction or error.

Event Description

The hospital reported patient cardiorespiratory arrest during use of the aespire mri.The patient was resuscitated with an ambu (artificial manual respiration unit) bag until the condition was reversed.Ge healthcare will submit a follow-up report when the investigation has been completed.

• 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: 15223512
• MDR Text Key: 304917693
• Report Number: 2112667-2022-02894
• 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: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2011
• 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): Required Intervention