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


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

MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTICSUN DEVICE Back to Search Results
Model Number 50000000L
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Use of Device Problem (1670); Temperature Problem (3022)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. Device evaluated by mfr: the device was evaluated by a biomedical technician at the complainant's facility.
Event Description
It was reported that the arctic sun device was not heating. The biomed ran a calibration check and the device passed all of the water temperature-related checks but did fail some flow-related checks. The event log had an alert 113 (reduced water temperature control) and an alert 114 (treatment stopped). The device was placed in manual mode with a water target of 42c. The water only went to 18. 6c by the end of the call. Per call back 15 minutes later, the water temperature had decreased to 14. 8c. The flow rate was 1. 9lpm. The heater pump command was running at 100%. The water level was at 5 bars. The device was drained, refilled, and placed in manual mode at 42c again. In 15 minutes, the water temperature was 32. 2c. The biomed was instructed to let it continue to run and to call back if the water temperature did not reach 42c. A second calibration check was also suggested.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARCTIC SUN 5000
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
MDR Report Key8568429
MDR Text Key145013818
Report Number1018233-2019-02245
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000L
Device Catalogue Number50000000L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse