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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 Patient Involvement (2645)
Event Date 01/15/2021
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, when assembling the arctic sun device, it was noted that the wires to t3 were twisted at the base causing one of the two wires to be connected by three strands of wires and the insulation was split. This part will be replaced under warranty as a preventive measure. Automated calibration and test system testing failed chiller efficiency at 10. 85 degrees c and post manual chiller efficiency test failed at the same temperature as well. The chiller will be replaced.
 
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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 Key11309057
MDR Text Key231351944
Report Number1018233-2021-00394
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 health professional,other,use
Reporter Occupation
Type of Report Initial
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2021
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: 02/10/2021 Patient Sequence Number: 1
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