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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE DATEX-OHMEDA ANES GE DATEX-OHMEDA ANESTHESIA MACHINE ANESTHESIA CART MACHINE

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GE DATEX-OHMEDA ANES GE DATEX-OHMEDA ANESTHESIA MACHINE ANESTHESIA CART MACHINE Back to Search Results
Model Number MODEL AESTIVA 5
Device Problem Failure to Deliver (2338)
Patient Problems Aspiration/Inhalation (1725); Pneumonia (2011); Vomiting (2144); Loss of consciousness (2418)
Event Date 10/10/2013
Event Type  Injury  
Event Description

Anesthesia machine quit working during anesthesia for cystoscopy and stent placement. Although we cannot know definitively it is suspected that the disruption in gas caused the patient to enter a semi-conscious state. Crna unable to ventilate patient as bag would not inflate on anesthesia machine. Patient began to bite down on airway and began to vomit. Patient aspirated vomitus and surgical case aborted. Patient able to undergo procedure the next day and was discharged home on antibiotics for aspiration pneumonia.

 
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Brand NameGE DATEX-OHMEDA ANESTHESIA MACHINE
Type of DeviceANESTHESIA CART MACHINE
Manufacturer (Section D)
GE DATEX-OHMEDA ANES
juputer FL 33468 7
MDR Report Key3427180
MDR Text Key3951933
Report NumberMW5032357
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
Type of Report Initial
Report Date 10/18/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/21/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL AESTIVA 5
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 10/21/2013 Patient Sequence Number: 1
Treatment
ANESTHESIA
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