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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 Problem Insufficient Cooling (1130)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2022
Event Type  malfunction  
Event Description
It was reported that the arctic sun device was not cooling. A functional check showed a failed mixing pump. Per response received via email on 12jan2022, biomed stated that the device was in use on a patient at the time of the event, there was no known harm and the patient completed therapy on a different device.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
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 was not cooling. A functional check showed a failed mixing pump. Per response received via email on 12jan2022, biomed stated that the device was in use on a patient at the time of the event, there was no known harm and the patient completed therapy on a different 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 Key13362106
MDR Text Key285410511
Report Number1018233-2022-00174
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 Other Health Care Professional
Type of Report Initial
Report Date 01/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2022
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/26/2022 Patient Sequence Number: 1
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