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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AVANCE ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AVANCE ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1009-9002-000
Device Problems Break (1069); Device Tipped Over (2589)
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 two front casters were replaced to resolve the reported issue.
 
Event Description
This report summarizes 1 malfunction event. A review of the event indicated that model 1009-9002-000 anesthesia gas machine experienced a broken caster causing the unit to lean which could cause the unit to tip or fall. The reported event did not involve a patient.
 
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Brand NameAVANCE
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 Key8773182
MDR Text Key150562512
Report Number2112667-2019-00236
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial
Report Date 07/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number1009-9002-000
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/01/2019
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

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