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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 04/21/2021
Event Type  malfunction  
Manufacturer Narrative
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.Unique identifier: (b)(4).A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The auxiliary common gas outlet (acgo) valve was replaced to resolve the issue.
 
Event Description
The hospital reported a large leak preventing mechanical ventilation.There was no report of patient involvement.
 
Manufacturer Narrative
Additional information was received that the leak was less than 750ml which would not affect ventilation.The initial event was not reportable.H3 other text: additional information was received that the leak was less than 750ml which would not affect ventilation.The initial event was not reportable.
 
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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 Key11864322
MDR Text Key255107391
Report Number2112667-2021-01309
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 05/24/2021
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 04/21/2021
Initial Date FDA Received05/21/2021
Supplement Dates Manufacturer Received05/24/2021
Supplement Dates FDA Received05/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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