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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 Sticking (1597)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/23/2018
Event Type  malfunction  
Manufacturer Narrative
The hospital reportedly removed and reinstalled the bellows after each occurrence. No report of patient involvement. (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, twice during a case, the bellows was noted to not return to the top of the bellows housing. There was no reported patient injury.
 
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Brand NameAVANCE CS2
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7525471
MDR Text Key108623667
Report Number2112667-2018-00993
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 foreign,health professional,u
Type of Report Initial
Report Date 05/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberSEE H10
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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