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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE, INC GE ADVANCE CS2 GAS-MACHINE, ANESTHESIA

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GE HEALTHCARE, INC GE ADVANCE CS2 GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number CS2
Device Problem Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2019
Event Type  malfunction  
Event Description
During surgery, the anesthesia machine shutdown unexpectedly. The anesthesia group quickly had the patient ventilating with an ambu bag and oxygen tank. Hooked patient up to transport monitor for vitals. Machine swapped out to a different anesthesia machine that was working appropriately. Approximately 25 minutes all together. Patient remained stable with vitals never changing.
 
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Brand NameGE ADVANCE CS2
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
GE HEALTHCARE, INC
3000 n grandview blvd
w-450
waukesha WI 53188
MDR Report Key8711751
MDR Text Key148450412
Report Number8711751
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCS2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/06/2019
Event Location Hospital
Date Report to Manufacturer06/19/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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