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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 Problem Energy Output Problem (1431)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/29/2020
Event Type  Malfunction  
Manufacturer Narrative

Customer contact reports no patient information available. (b)(4). The customer biomedical engineer troubleshot the reported issue with ge healthcare technical support. It was recommended to replace the absorbent.

 
Event Description

The hospital reported the unit would not drive the bellows preventing mechanical ventilation. There was no report of 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 53718
Manufacturer Contact
john szalinski
MDR Report Key10453744
MDR Text Key204365811
Report Number2112667-2020-02337
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172045
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 08/26/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1009-9050-000
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 Received07/29/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/13/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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