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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 Stops Intermittently (1599)
Patient Problem No Information (3190)
Event Date 06/14/2016
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the equipment and a review of the logs. The anesthesia control board was replaced and the equipment was returned to service.
 
Event Description
The hospital reported that the unit shut down. It is unknown if there was any patient involvement.
 
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Brand NameAVANCE CS2
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI 53718
Manufacturer Contact
stephanie cass
3000 n. grandview boulevard
waukesha, WI 53188
MDR Report Key5794412
MDR Text Key49537799
Report Number2112667-2016-01315
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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