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

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement. Unique identifier: (b)(4). A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The absorbent canister was replaced to resolve the reported issue.

Event Description

The hospital reported a leak large enough to cause a loss of mechanical ventilation. There was no report of patient involvement.

Manufacturer Narrative

Additional information was received that the leak was less than 4. 5lpm. A preop check of the machine, as contained in the user manual, will pick up such a condition. As stated in the report, the preop test failed, notifying the user of the reported condition. The leak may be able to be compensated for or made up with fresh gas flow. H3 other text: additional information was received that the leak was less than 4. 5lpm. A preop check of the machine, as contained in the user manual, will pick up such a condition. As stated in the report, the preop test failed, notifying the user of the reported condition. The leak may be able to be compensated for or made up with fresh gas flow.

• 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: john szalinski
• MDR Report Key: 11715555
• Report Number: 2112667-2021-01101
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage