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

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 03/06/2017

Event Type  Death  

Manufacturer Narrative

A gehc service representative performed a checkout of the equipment and confirmed mechanical ventilation was not functional due to the damage by the mri magnet.The gauss alarm was checked and found to be functional.The central processing unit , the gas inlet valve solenoid valve, the flow valve and the flow control sensors were replaced.As stated in the aestiva mri manual: ¿the aestiva/5 mri does contain some ferromagnetic material and will be attracted to the mr imager if positioned closer than 300 gauss.Always keep the aestiva/5 mri in a fringe field of 300 gauss or less.¿ patient information could not be obtained due to country privacy laws.The date of death was not specified.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.

Event Description

The hospital reported that, prior to patient use, the unit was in the mri room.The staff reportedly noted the length of the patient circuit that was chosen to use for the case was too short.The staff reportedly removed the locks from the anesthesia machine wheels and moved the machine closer to the mri magnet, drawing the machine into the magnet.The staff reportedly pulled the machine away from the magnet and placed the machine into patient use.It was further reported a check of the anesthesia machine was not performed subsequent to the attraction to the mri magnet and prior to use on the patient.At some point during the case, mechanical ventilation stopped and the patient went into cardiac arrest.The patient was resuscitated during transport but subsequently died.

Manufacturer Narrative

Additional information was received that the original timeline of events was incorrect.The staff reportedly removed the locks from the anesthesia machine wheels and moved the machine closer to the mri magnet, drawing the machine into the magnet during a case.A functionality check of the unit was not performed before the case was continued.The initial mdr indicated the machine was drawn into the magnet prior to the case.Corrected information: corrected to (b)(6) 2017.Become aware date changed to the date that the ge healthcare service rep discovered the adverse event was as a result of the loss of mechanical ventilation and not a preexisting "cardiac problem".

• Brand Name: AESTIVA MRI
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL
• MDR Report Key: 6461199
• MDR Text Key: 71755697
• Report Number: 2112667-2017-00638
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K993410
• 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: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death