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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 Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/17/2017
Event Type  malfunction  
Manufacturer Narrative
A gehc service representative performed a checkout of the equipment and confirmed the reported complaint. The auxiliary oxygen flowmeter knob and screw were replaced. Patient information could not be obtained due to country privacy laws. (b)(4). The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws.
 
Event Description
The hospital reported that the knob was missing from the auxiliary flowmeter.
 
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Brand NameAVANCE CS2
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI
Manufacturer Contact
john szalinski
540 w. northwest highway
barrington, IL 
MDR Report Key6412772
MDR Text Key70310848
Report Number2112667-2017-00519
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K132530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 03/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberSEE BLOCK H10
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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