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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
Lot Number APWX02633
Device Problem Gas Leak (2946)
Patient Problem Insufficient Information (4580)
Event Date 06/01/2021
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 absorbant canister was replaced to resolve the reported issue.

 
Event Description

The hospital reported a malfunction causing a potential leak in excess of 4. 5 lpm. There was no report of patient involvement.

 
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Brand NameAISYS CS2
Type of DeviceANESTHESIA 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 Key12097195
MDR Text Key261921775
Report Number2112667-2021-01658
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
PMA/PMN NumberK132530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Type of Report Initial
Report Date 06/30/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device LOT NumberAPWX02633
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/01/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/05/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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