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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AVANCE CS2 ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AVANCE CS2 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem No Flow (2991)
Patient Problems Death (1802); Hypoxia (1918)
Event Date 01/24/2020
Event Type  Death  
Manufacturer Narrative
Ge healthcares investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. Device evaluation anticipated, but not yet begun.
 
Event Description
Ge healthcare was notified that, during knee surgery, there was no fresh gas flow coming from the patient y-connector both in bag and vent mode and pressure inside the bag was not released even when the patient y-connector is open, resulting in patient hypoxic arrest and subsequent patient death.
 
Manufacturer Narrative
A ge healthcare (gehc) field engineer (fe) performed a checkout of the system and did not confirm the reported issue. Gehc product engineering performed a root cause investigation of this event. Gehc engineering received and reviewed the service logs pulled from the device as well as pictures taken of the inspiratory flow check valve. Based on the customer observations of taut bag, no flow, lack of alarms other than negative pressure in the patient circuit, as well as the audible "pop"쳌 heard as gas flow began, potential root causes were narrowed to the inspiratory check valve stuck fully closed. The inspiratory check valve was replaced by the gehc fe. The root cause of the lack of flow cannot be determined due to the inability to reproduce the issue or have the suspected part returned for further analysis.
 
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Brand NameAVANCE CS2
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 Key9726632
MDR Text Key179958993
Report Number2112667-2020-00452
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2020
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 Received04/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/11/2013
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: 02/19/2020 Patient Sequence Number: 1
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