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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 Suction Problem (2170)
Patient Problem No Patient Involvement (2645)
Event Date 12/12/2017
Event Type  malfunction  
Manufacturer Narrative
A gehc service representative performed a checkout of the equipment and confirmed the reported complaint. Inspection of the equipment noted that the overflow safety trap was stuck in the top position the safety trap was released. (b)(4).
 
Event Description
The hospital reported the suction unit was not functional. 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
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7155590
MDR Text Key96113068
Report Number2112667-2017-02431
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 12/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberSEE H10
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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