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

Model Number 1006-9310-000

Device Problem Alarm Not Visible (1022)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, a ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The pca mri alarm board was replaced to resolve the reported issue.

Event Description

This report summarizes 1 malfunction event.A review of the event indicated that model 1006-9310-000 anesthesia gas machine had malfunction of the mri distance alarm preventing alerts to the user when the unit is brought too close to the mri magnetic field.This report was from a single source.This event did not involve a patient.

• Brand Name: AESTIVA MRI
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 8480310
• MDR Text Key: 141024213
• Report Number: 2112667-2019-00036
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00840682102339
• UDI-Public: 010084068210233921
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1006-9310-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2019
• 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