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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AISYS ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Death (1802)
Event Date 04/15/2019
Event Type  Death  
Manufacturer Narrative
Ge healthcare's investigation into the reported occurrence is 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. Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital asked for a functional check of the system after they reported difficulty ventilating a patient. The patient died during the surgery procedure.
 
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Brand NameAISYS
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key8598793
MDR Text Key144663056
Report Number2112667-2019-00185
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K042154
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 06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2019
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/04/2019
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

Patient Treatment Data
Date Received: 05/10/2019 Patient Sequence Number: 1
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