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

Device Problem No Visual Prompts/Feedback (4021)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that there was a malfunction resulting in the loss of display during a case.There was no patient injury.

Manufacturer Narrative

The customer declined ge service.No repair information available.Block a: patient information could not be obtained due to country privacy laws.Â â  legal manufacturer: hcs madison 3030 ohmeda dr, usa, madison, wi.53718.

• 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: 18930332
• MDR Text Key: 338003823
• Report Number: 2112667-2024-01499
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00840682102292
• UDI-Public: 0100840682102292
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 03/19/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2020
• 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