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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
Model Number 50000000
Device Problems Defective Component (2292); Computer Operating System Problem (2898)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the arctic sun device had issues in the message "restart" displayed during use. The issue was resolved after a restart. Noted that the device was replaced and under investigation. Per follow-up information on 17sep2021, it was noted that the device was swapped for a second arctic sun device and patient information was unknown and date of event occurred on (b)(6) 2021. Per follow-up information on 17sep2021, it was noted that the device was under imi investigation and sent to bd evaluation. Customer stated that there was no impact to the patient while using the device.
 
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Brand NameARCTIC SUN® 5000
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key12578675
MDR Text Key274933684
Report Number1018233-2021-06227
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/05/2021 Patient Sequence Number: 1
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