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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA AESTIVA ANESTHESIA MACHINE
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DATEX-OHMEDA AESTIVA ANESTHESIA MACHINE Back to Search Results
Device Problems Fire (1245); Sparking (2595)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 02/28/2012
Event Type  Injury  
Event Description

The hospital reported that, while doing a monitored anesthesia care (mac) case for removal of a facial cyst, the clinician was utilizing a cautery device and delivering 8 liters per minute (lpm) of oxygen via a nasal cannula from the aestiva auxiliary flowmeter. A spark was reportedly created while using the cautery device, and a fire started. The pt reportedly sustained second degree burns and was subsequently transferred to another hospital for treatment. There was no report of equipment malfunction. Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed.

 
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Brand NameAESTIVA
Type of DeviceANESTHESIA MACHINE
Manufacturer (Section D)
DATEX-OHMEDA
madison WI
Manufacturer (Section G)
DATEX-OHMEDA INC.
madison WI
Manufacturer Contact
joy sonsalla
3000 n. grandview blvd
waukesha, WI 53188
2625482661
MDR Report Key2508898
MDR Text Key2598060
Report Number2112667-2012-00013
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK973896
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 02/28/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2012
Is This An Adverse Event Report? No
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 Received02/28/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/01/2004
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: 03/27/2012 Patient Sequence Number: 1
Treatment
ELECTROCAUTERY DEVICE, UNSPECIFIED MANUFACTURER
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