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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. AISYS ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Burn, Thermal (2530); Cancer (3262)
Event Date 12/14/2012
Event Type  Injury  
Event Description

The hospital reported that, during a surgical procedure involving an end-of-life pt that is dying from "severe untreatable" lung cancer, the surgeon was attempting to make an opening to facilitate the pt getting more air, prior to placing the pt at hospice. The surgeon was using a laser and documented in the medical record that, while lasering the tumor, the tumor caught fire. The fire reportedly went half was up the pt circuit. The fire was immediately extinguished. Subsequently, a bronchoscope was used to determine the extent of damage to the pt, if any. It was determined that the pt had charring inside the bronchial area. The pt also sustained a burn on the face.

 
Manufacturer Narrative

Ge healthcare's investigation is ongoing. A f/u report will be submitted once the investigation has been completed.

 
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Brand NameAISYS
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
madison WI
Manufacturer Contact
joy sonsalla
3000 n. grandview blvd.
waukesha, WI 53188
2625482661
MDR Report Key2912784
MDR Text Key3217999
Report Number2112667-2013-00001
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK042154
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 12/14/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/14/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/01/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 01/08/2013 Patient Sequence Number: 1
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