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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS CS2; ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. AISYS CS2; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2021
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 flow sensor manifold assembly was replaced to resolve the issue.
 
Event Description
The hospital reported a leak greater than 4.5lpm resulting in the loss of all ventilation modes.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.
 
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Brand Name
AISYS CS2
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key11692841
MDR Text Key248823866
Report Number2112667-2021-01056
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K132530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2021
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
Date Manufacturer Received04/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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