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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
Lot Number APKY01140
Device Problem No Device Output (1435)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Legal manufacturer: hcs (b)(4). A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The gas mixer, ventilator board, solenoid, and flow control valve were replaced to resolve the reported issue. Date received by manufacturer: this mdr malfunction event was previously eligible for the voluntary malfunction summary reporting (vmsr) program. As of 9/16/2019 notification from fda, this product code is no longer eligible for vmsr. According to the notification, ge healthcare must submit individual reports within 30 calendar days of receiving the notification. Therefore, this event is being reported as an individual mdr report due 10/16/2019.

 
Event Description

The hospital reported an error message preventing mechanical ventilation. There was no report of patient involvement.

 
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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
joseph seliga
3000 n grandview blvd.
waukesha, WI 
MDR Report Key9085090
MDR Text Key196167097
Report Number2112667-2019-00432
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
PMA/PMN NumberK123125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Type of Report Initial
Report Date 09/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT NumberAPKY01140
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/16/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/24/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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