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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/25/2022
Event Type  malfunction  
Event Description
It was reported that biomed stated that the arctic sun device was getting low flow alerts and the inlet pressure was 0. 0psi. The device had a bad circulation pump, and the system hours were 9416. Per sample evaluation results received on (b)(6) 2022, it was noted that the hot side connection between the power inlet module and the main voltage circuit card and the chiller power connector to the main voltage circuit card show signs of electrical overstress. It was stated that windows errors detected on the control panel screen during therapy mode causing the screen to freeze. The speaker volume was barely audible on the highest volume setting. The molded y tube from the chiller pump to the evaporator tank had cuts found in it. The tank seals were lifting from the tank. The double-bend tube had deformation and expansion. A pinhole in the control panel clear screen cover was noted with stains found under the clear plastic screen cover. It was also stated that it did not appear to affect touchscreen functionality. It was also noted the arctic sun device would not autofill.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
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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 Key15208465
MDR Text Key303219437
Report Number1018233-2022-06272
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741127755
UDI-Public(01)00801741127755
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
Type of Report Initial
Report Date 07/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2022
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? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/25/2022
Was Device Evaluated by Manufacturer? No
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: 08/11/2022 Patient Sequence Number: 1
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