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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. GENERAL ELECTRIC AVANCE CS2 ANESTHESIA MACHINE AVANCE CS2 GAS-MACHINE, ANESTHESIA

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DATEX-OHMEDA, INC. GENERAL ELECTRIC AVANCE CS2 ANESTHESIA MACHINE AVANCE CS2 GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number AVANCE CS2
Device Problems Product Quality Problem (1506); Defective Device (2588); Gas Leak (2946)
Patient Problem Insufficient Information (4580)
Event Date 07/30/2021
Event Type  Injury  
Event Description

The ge advance cs2 anesthesia machine failed to detect a 10 liter/min fresh gas flow leak during it's set up procedures (the full leak-test procedure the manufacturer set as required on initiation of the machine's use). This is the second time this model (different machine) has done this: failed to detect a 10 lpm flow leak during it's full leak-test. This is absolutely unacceptable and i have never seen such poor qi/qa on the part of an anesthesia machine manufacturer in my 19 years of anesthesia practice (i am an anesthesiologist). Fda safety report id# (b)(4).

 
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Brand NameGENERAL ELECTRIC AVANCE CS2 ANESTHESIA MACHINE AVANCE CS2
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
DATEX-OHMEDA, INC.
MDR Report Key12275732
MDR Text Key265179514
Report NumberMW5102968
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/31/2021
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received08/03/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberAVANCE CS2
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/03/2021 Patient Sequence Number: 1
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