MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7100; ANESTHESIA GAS MACHINE

Model Number 1006-9321-000

Device Problems Nonstandard Device (1420); Unauthorized Access to Computer System (3025)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Event not reported on any specific serial numbers.For the reported event, ge healthcare (gehc) reported a field modification for this issue per 21 cfr 806 on 25 july 2019.The gehc internal field modification number is fmi 34101.Customers were sent a letter explaining the issue and were informed that if they choose to connect ge healthcare anesthesia device serial ports to tcp/ip networks, they should ensure that sufficiently secured terminal servers are used.Secure terminal servers provide robust security features that will prevent this issue.

Event Description

This report summarizes 1 malfunction event.A review of the event indicated that model 1006-9321-000 anesthesia gas machine was reported for the communication protocol allowing the performance of remote intrusive actions with no authentication.This report was received from a third party cybersecurity expert.The reported event did not involve a patient.

• Brand Name: AESTIVA 7100
• 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: 8830830
• MDR Text Key: 175032262
• Report Number: 2112667-2019-00369
• Device Sequence Number: 0
• Product Code: BSZ
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Device Operator: Health Professional
• Device Model Number: 1006-9321-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Type of Device Usage: N
• Removal/Correction Number: FMI34101
• Patient Sequence Number: 1