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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 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.
 
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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 Key11755621
MDR Text Key250626810
Report Number2112667-2021-01153
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 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 Received04/30/2021
Supplement Dates Manufacturer Received05/03/2021
Supplement Dates FDA Received05/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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