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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE MEDIVANCE ARCTIC SUN

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MEDIVANCE MEDIVANCE ARCTIC SUN Back to Search Results
Model Number 2000
Device Problem Burn of device or device component
Event Date 12/05/2005
Event Type  Injury  
Event Description

Arctic sun machine was being used to lower body temperature on head trauma patient. Nurses noted breakdown of skin integrity at sites where cooling blanket was placed on patient. See scanned page.

 
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Brand NameMEDIVANCE
Type of DeviceARCTIC SUN
Manufacturer (Section F)
MEDIVANCE
louisville CO
Manufacturer (Section D)
MEDIVANCE
louisville CO
Device Event Key938000
MDR Report Key965037
Event Key629400
Report Number965037
Device Sequence Number1
Product CodeDWJ
Report Source User Facility
Source Type Unknown
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 12/20/2005
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2005
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number2000
Is The Reporter A Health Professional? No
Distributor Facility Aware Date12/09/2005
Event Location Hospital
Date Report TO Manufacturer12/09/2005
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 12/30/2005 Patient Sequence Number: 1
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