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

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.

• 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 Key: 12520428
• MDR Text Key: 272949708
• Report Number: 1018233-2021-05914
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• 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 Number: 50000000
• Device Catalogue Number: 50000000
• 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 Received: 09/23/2021
• Supplement Dates Manufacturer Received: 03/30/2022
• Supplement Dates FDA Received: 04/25/2022
• 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 Number: 1
• Patient Outcome(s): Other