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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 Problem Gas Leak (2946)
Patient Problems Hypoventilation (1916); No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Serial number: (b)(4). For 6 of the 6 reported events, a ge healthcare service representative performed a checkout of the system and confirmed the reported events. The bag arm hose was replaced to resolve 1 reported event, the adjustable pressure limit valve was replaced to resolve 1 event, the auxiliary common gas outlet output tube #104 was re-connected to resolve 1 event, the condenser e-z tubing was replaced to resolve 1 event, the o-ring at the co2 absorber connection to the circuit was replaced to resolve 1 event. For 1 event, replacement of the bellows and pop-off valve was recommended the customer.

 
Event Description

This report summarizes 6 malfunction events. A review of the events indicated that model 1009-9002-000 anesthesia gas machine experienced gas leaks. 4 events were reported for a malfunction causing a leak of more than 4. 5l per minute affecting ventilation, 2 events reported for a leak resulting in loss of ventilation. These reports were received from various sources. Of the 6 events, 5 did not involve a patient, and 1 did involve a patient. There was no patient information available.

 
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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 Key8488196
MDR Text Key145236532
Report Number2112667-2019-00075
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Number of Events Reported5
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 06/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/05/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number1009-9002-000
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/03/2019
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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