MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS CS2; ANESTHESIA GAS MACHINE

Model Number 1011-9050-000

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Event Description

It was reported that there was a malfunction resulting in system shutdown during a case.The patient was switched to manual ventilation.There was no patient injury.

Manufacturer Narrative

Ge healthcareâs investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Block a: there was no patient information available at time of mdr submission.Legal manufacturer: hcs madison 3030 ohmeda dr, usa, madison, wi.53718.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The display was replaced to resolve the issue.Block a: no patient information provided to date after calls to customer 04/24/24 and 05/06/24.

• Brand Name: AISYS CS2
• 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: 19050999
• MDR Text Key: 339572869
• Report Number: 2112667-2024-01853
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00840682102292
• UDI-Public: 0100840682102292
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/07/2024

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
• Device Model Number: 1011-9050-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/21/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2023
• 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