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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
Model Number 1009-9050-000
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Physical Resistance/Sticking (4012)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
For the reported event, a ge healthcare service representative performed a checkout of the system and confirmed the reported event.The flow sensor was recommended for replacement.
 
Event Description
This report summarizes 1 malfunction event.A review of the event indicated that model 1009-9050-000 anesthesia gas machine experienced a defective flow sensor with a stuck open membrane.The report was received from a single source.The reported event did not involve a patient.
 
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Brand Name
AVANCE CS2
Type of Device
ANESTHESIA 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 Key8786357
MDR Text Key151024656
Report Number2112667-2019-00270
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier00840682102322
UDI-Public010084068210232221
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial
Report Date 07/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1009-9050-000
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/01/2019
Initial Date FDA Received07/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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