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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 Suction Problem (2170)
Patient Problem No Patient Involvement (2645)
Event Date 10/01/2018
Event Type  malfunction  
Manufacturer Narrative
The hospital has not accepted the proposal for service from ge healthcare. No report of patient involvement.
 
Event Description
The hospital reported suction was not operating as expected. 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
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key8024126
MDR Text Key125650948
Report Number2112667-2018-02156
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 10/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2018
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 Received10/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/17/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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