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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ARCTIC SUN 5000 SYSTEM, THERMAL REGULATING

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MEDIVANCE, INC. ARCTIC SUN 5000 SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 50000000E
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Protective Measures Problem (3015); Temperature Problem (3022)
Patient Problem Insufficient Information (4580)
Event Date 01/10/2021
Event Type  malfunction  
Event Description
Cooling device failed. Per report, when it was placed, an error message appeared - e113. This is a water temperature notification that it is not being temperature controlled. The device was pulled out of service and tested by biomedical department. They noted another error message -e80. This means the control processor failed to detect a simulated water temperature fault. Biomed contacted the vendor who reported the mixing pump was not working correctly. It was not pushing enough cold water into the lines to cool the patient to the correct temperature. The vendor noted the pump needed to be replaced. The unit was sent to the vendor for repair. Biomed also had another unit with the same issue and it too was sent for repair. Biomed reported the units had appropriate preventative maintenance. Manufacturer has not responded to date for either unit.
 
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Brand NameARCTIC SUN 5000
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
MEDIVANCE, INC.
321 south taylor avenue suite 200
louisville CO 80027
MDR Report Key11214170
MDR Text Key228170154
Report Number11214170
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 Risk Manager
Type of Report Initial
Report Date 01/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/12/2021
Event Location Hospital
Date Report to Manufacturer01/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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