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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 Device Displays Incorrect Message (2591)
Patient Problem Brain Injury (2219)
Event Date 08/03/2018
Event Type  Injury  
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. (b)(4). Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported that the pulse oximeter was not displaying an accurate peripheral oxygen saturation during a case. It was further reported that this resulted in an anoxic brain injury.
 
Manufacturer Narrative
Correction to date of event: incident date has been corrected to (b)(6) 2018.
 
Manufacturer Narrative
A gehc service representative performed a checkout of the equipment and found it to function within manufacturers specifications. The logs were downloaded and reviewed. The logs do not indicate any equipment malfunction.
 
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Brand NameAVANCE CS2
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key7875159
MDR Text Key120237246
Report Number2112667-2018-01800
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K123125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2018
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 Received12/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/13/2018 Patient Sequence Number: 1
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