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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTIC SUN DEVICE Back to Search Results
Catalog Number 5000-01-03
Device Problems Insufficient Cooling (1130); Computer Operating System Problem (2898); Pressure Problem (3012)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that the arctic sun device would not get the cooling setting. After troubleshooting the arctic sun device hardware, the therapy was better, but still would not achieve the required temperature. The arctic gel pads were then changed and the complainant used another device and the target temperature was then achieved. Per follow up via ibc on 04aug2020, the arctic sun device not getting the required temperature of cooling. The user changed the arctic gel pad on the different arctic sun device and completed the therapy. Per follow up via ibc on 05aug2020, the user tried to troubleshoot the connection of the arctic gel pads with no response. The next troubleshoot was to check the flow with a connector which showed that there was no issue with the arctic sun device. The arctic gel pads were changed for some reason and this would not work either, then the arctic sun device was changed as well to manage to get the correct therapy. The changing of the arctic gel pad was a part of troubleshooting. Per follow up via ibc on 12aug2020, there was an issue with the psi rate, which intern inhibits the ability to cool. The psi rate could be affected by the poor connection, hence this was a first troubleshooting method to check the connection. After troubleshooting, the user could not get a good psi on the hardware which was displayed as zero. Per troubleshooting, the arctic gel pad connection was checked which would not work, then changed the arctic gel pads which still would not work. The user originally thought it could be a batch issue with the arctic gel pad as the customer has already experienced an issue with the same batch arctic gel pad. Hence, the user changed to a new arctic sun device and was able to achieve the correct psi rate (0. 9 -1. 5).
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC SUN DEVICE
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
7707846100
MDR Report Key10493803
MDR Text Key206785073
Report Number1018233-2020-05695
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K161602
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 11/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5000-01-03
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 Received10/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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