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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 50000000E
Device Problem Intermittent Loss of Power (4016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/23/2021
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 alerted and then turned off when patient had been on device. The user tried turning back on device but it would not power on. The user verified device was not plugged into bed. Also noted if the device would not power on, they would need to swap out for new device and send the device to biomed for evaluation. Per follow up via nurse on 30apr2021,1st device sent to biomed and patient completed therapy on second 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 Key11838105
MDR Text Key251116326
Report Number1018233-2021-02862
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
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 Physician Assistant
Type of Report Initial,Followup
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/24/2018
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: 05/17/2021 Patient Sequence Number: 1
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