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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 Insufficient Heating (1287); Overfill (2404)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2021
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 water temperature could increase only at 31 degree c in spite of setting at 34 degree c on arctic sun device during use for a patient. Also, it was found that too much water injection introduced the result. The device was switched to the second one and under investigation at imi on may 24. Per follow up via ibc on (b)(6) 2021, therapy was completed with the substitute 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 Key12014289
MDR Text Key256695863
Report Number1018233-2021-03586
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 11/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
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
Date Returned to Manufacturer05/24/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2020
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: 06/17/2021 Patient Sequence Number: 1
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