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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN 5000

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN 5000 Back to Search Results
Model Number 50000000
Device Problem Computer Operating System Problem (2898)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2021
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 error 64 occurred during maintenance of the arctic sun device.
 
Event Description
It was reported that error 64 occurred during maintenance of the arctic sun device.
 
Manufacturer Narrative
The reported issue was unconfirmed.The root cause was unable to be determined as the reported issue was not able to be duplicated.The device was evaluated, and the reported issue was not able to be duplicated.No repairs were made.The device underwent a calibration and functional check.The device passed all applicable tests.The investigation indicated that the reported issue was not manufacturing, or supplier related.Therefore, a device history record review was not required.The reported event is unconfirmed, therefore labeling/packaging review is not required.The actual/suspected device was inspected.
 
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Brand Name
ARCTIC SUN® 5000
Type of Device
ARCTIC SUN 5000
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 Key12520428
MDR Text Key272949708
Report Number1018233-2021-05914
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
Combination Product (y/n)N
Reporter Country CodeJA
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 Physician
Type of Report Initial,Followup
Report Date 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/01/2021
Initial Date FDA Received09/23/2021
Supplement Dates Manufacturer Received03/30/2022
Supplement Dates FDA Received04/25/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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