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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ARCTIC SUN STAT SYSTEM, THERMAL REGULATING

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MEDIVANCE, INC. ARCTIC SUN STAT SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 60000000
Device Problems Device Displays Incorrect Message (2591); Temperature Problem (3022)
Patient Problem Insufficient Information (4580)
Event Date 10/24/2021
Event Type  malfunction  
Event Description
Around hour 66-67 of therapeutic hypothermia (of 72 total), the arctic sun cooling machine began giving an error message/alarm that it was not "adjusting the temperature as accurately as predicted". The water temperature began dropping. Call was placed to arctic sun helpline and instruction was to switch out the machine to a new unit.
 
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Brand NameARCTIC SUN STAT
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
MEDIVANCE, INC.
321 south taylor avenue
suite 200
louisville CO 80027
MDR Report Key12851321
MDR Text Key281082331
Report Number12851321
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/17/2021,11/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number60000000
Device Catalogue Number60000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/17/2021
Event Location Hospital
Date Report to Manufacturer11/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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