MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN STAT; ARCTIC SUN DEVICE

Model Number 60000000

Device Problems Defective Component (2292); Computer Operating System Problem (2898)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/06/2023

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 booted repeatedly to an alarm 80 (non-recoverable system error).Mis stated this was indicative of a loose or failed processor circuit card.Mis recommended to remove the panels of the device and inspect the circuit cards and reseat them.If that did not resolve the issue they could bring it back for depot service.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is due to a failed processor circuit card.Received error 80, installed a test processor card to perform.Replaced the processor circuit card.The arctic sun 6000 passed all performance testing, calibration, electrical safety tests and is functioning properly.Unit is ready for use.The device did not meet specifications, and was influenced by the reported failure.It is unknown if the device was in use on a patient.The dhr is not required as this is event not an out-of-box failure and therefore is not manufacturing related.Based on the results of this investigation, no additional actions are required.The labelling review is not required as the complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the arctic sun device booted repeatedly to an alarm 80 (non-recoverable system error).Mis stated this was indicative of a loose or failed processor circuit card.Mis recommended to remove the panels of the device and inspect the circuit cards and reseat them.If that did not resolve the issue they could bring it back for depot service.

• Brand Name: ARCTIC SUN STAT
• Type of Device: ARCTIC 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16225052
• MDR Text Key: 308478903
• Report Number: 1018233-2023-00231
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741161513
• UDI-Public: (01)00801741161513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200225
• 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: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60000000
• Device Catalogue Number: 60000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• 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