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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE/DATEX-OHMEDA, INC. AVANCE ANESTHESIA UNIT GAS-MACHINE, ANESTHESIA

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GE HEALTHCARE/DATEX-OHMEDA, INC. AVANCE ANESTHESIA UNIT GAS-MACHINE, ANESTHESIA Back to Search Results
Device Problem Short Fill (1575)
Patient Problems Cardiopulmonary Arrest (1765); Low Oxygen Saturation (2477)
Event Date 01/23/2019
Event Type  Injury  
Event Description

On (b)(6) 2019 a (b)(6) yo male underwent a right knee l&d w/ spinal anesthesia. Procedure converted to general anesthesia for pain management, patient was induced w/ propofol & succinylcholine. Patient was ventilated with anesthesia circuit, then manually by ambu bag as bag was unable to fill with 02 flush or high flow 02. Patient intubated w/ minimal desat during induction; patient went asystole, acls started. Procedure aborted. Patient to icu intubated and w/o response, sedated and paralyzed as per hypothermic protocol.

 
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Brand NameAVANCE ANESTHESIA UNIT
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
GE HEALTHCARE/DATEX-OHMEDA, INC.
MDR Report Key8343229
MDR Text Key137075283
Report NumberMW5084084
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 Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
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: 02/14/2019 Patient Sequence Number: 1
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