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U.S. Department of Health and Human Services

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

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GE HEALTHCARE AVANCE CS2 GAS-MACHINE, ANESTHESIA Back to Search Results
Device Problems Occlusion Within Device (1423); Material Rupture (1546)
Patient Problems Bradycardia (1751); Death (1802); High Blood Pressure/ Hypertension (1908); Hypoxia (1918)
Event Date 01/05/2016
Event Type  Death  
Event Description

The anesthesiologist was asked to anesthetize patient. During intubation the patient became hypoxic. Ventilation was difficult and there was on going bradycardia and hypertension. It was noted that the co2 waveform was flat and not correlating with ventilation breathes or compressions. Severe ventilation effort was noted and correct ett placement was verified with fluoroscopy. The required ventilation effort caused the ventilation bag to rupture. During replacement of the ventilation bag other circuit connections were checked and a rubber test stopper was found occluding the output port of the anesthesia machine. The stopper was removed and the patient was reintubated. Ventilation normalized and skin color improved.

 
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Brand NameAVANCE CS2
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
GE HEALTHCARE
9900 w innovation drive
mail stop: rp-2138
wauwatosa, WI 53226
MDR Report Key5382443
MDR Text Key36486881
Report Number5382443
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 01/15/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/21/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/15/2016
Device Age5 mo
Event Location Hospital
Date Report TO Manufacturer01/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/21/2016 Patient Sequence Number: 1
Treatment
NO
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