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 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier: (b)(4).No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The advanced breathing system was cleaned to resolve the reported issue.

Event Description

The hospital reported the unit had a large leak.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
• MDR Report Key: 11755621
• MDR Text Key: 250626810
• Report Number: 2112667-2021-01153
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K132530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/30/2021
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1