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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 Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2022
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 had a failed mixing pump and the biomed would like to send the device in for 2000 hours preventive maintenance. Per sample evaluation results received on (b)(6) 2022, the isolation circuit was pulled forward and no longer seated in the card cage. Upon removing the circuit card from the cage, it was discovered that both patient temperature 1 (pt1), patient temperature 2 (pt2), and the echo output channel lemo solder connections to the circuit card were broken free and the echo channel is missing the lemo retaining ring. The chiller outlet l tube and the double bend tube from the tank to the manifold had both expanded.
 
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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 Key14487562
MDR Text Key292504060
Report Number1018233-2022-04027
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
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,Followup
Report Date 08/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2022
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? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2013
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: 05/24/2022 Patient Sequence Number: 1
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