• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCEMEDIVANCEARCTIC SUN

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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   Patient Outcome  Required Intervention
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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?

-
-