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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 5000-01-01
Device Problems Insufficient Cooling (1130); Overfill (2404)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2022
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 was not cooling anymore. Per sample evaluation results received on 02may2022, it was observed that the device was overfilled. Temperature (t1) or temperature (t2) sensors falls with chiller activity near temperature (t4) sensor. Per follow up information received on 03may2022, there was no patient involvement and the device would be serviced.
 
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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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key14440456
MDR Text Key292194832
Report Number1018233-2022-03920
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeGM
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 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5000-01-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2011
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: 05/19/2022 Patient Sequence Number: 1
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