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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 07/31/2020
Event Type  Malfunction  
Manufacturer Narrative

Ge healthcare investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. The customer contact reports no patient information is available. Unique identifier: (b)(4). Device evaluation anticipated, but not yet begun.

 
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 Key10466391
MDR Text Key224800977
Report Number2112667-2020-02380
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,Followup
Report Date 09/11/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/28/2020
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/31/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/07/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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