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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 Device Operates Differently Than Expected (2913)
Patient Problem Pneumothorax (2012)
Event Date 01/04/2018
Event Type  Injury  
Manufacturer Narrative
A gehc service representative performed a checkout of the equipment and confirmed the reported complaint. The drive gas check valve was replaced. The replaced part was returned to the manufacturing site for investigation. The valve was tested and the reported complaint could not be duplicated.
 
Manufacturer Narrative
Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed. Patient information could not be obtained due to country privacy laws. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws.
 
Event Description
The hospital reported that, during a case, the unit alarmed for co2. The clinician reportedly switched to manual ventilation, replaced the sodalime, and drained the condenser. The clinician reportedly switched back to mechanical ventilation. The clinician reportedly pressed the oxygen flush button to inflate the bellows, however, the bellows did not inflate. The unit reportedly alarmed for high pressure. The clinician reportedly switched the patient to an external circuit to maintain ventilation. The clinician replaced the patient circuit on the anesthesia machine, however, this action reportedly did not resolve the high pressure condition. The anesthesia machine was replaced. An x-ray was taken of the patient's lungs and a pneumothorax was reportedly noted.
 
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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
3000 n grandview blvd.
waukesha, WI 53188
8479711808
MDR Report Key7251845
MDR Text Key106759850
Report Number2112667-2018-00268
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 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/08/2018 Patient Sequence Number: 1
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