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

Model Number 50000000

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2022

Event Type  malfunction  

Event Description

It was reported that on the arctic sun device water did not flow when they paused it during use and tried to use it again.An alarm occurred.The therapy was completed on the second device.The device would be evaluated at the imi facility on (b)(6) 2021.Per follow up information received via email on (b)(6) 2022, the device was under evaluation at the imi facility.It was unknown about the alarm code.The date of event occurred was (b)(6) 2022.The second device was used.Per follow up information received via email on (b)(6) 2022, the only information available was that the system was temporarily interrupted for inspection while a patient was using it, and when it was restarted afterwards, the water flow did not flow, and an alarm sounded.There was no detailed information about the alarm.The device was used on the patient but no impact to the patient.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported issue was unconfirmed.The root cause of the reported issue was unable to be determined, as the reported issue could not be duplicated during evaluation.The device was evaluated upon receipt.An additional alarm is observed.No repairs were made towards the alarm issue, as it was not reproduced during evaluation.Arctic sun passed all tests successfully and unit is ready to be returned to the customer.It is unknown whether the device was influenced by the reported failure, however the device met specifications.The device was in use on a patient.The reported event is unconfirmed, therefore dhr review and labeling/packaging review are not required.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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that on the arctic sun device, water did not flow when they paused it during use and tried to use it again.An alarm occurred.The therapy was completed on the second device.The device would be evaluated at the imi facility on 24apr2021.Per follow-up information received via email on 12aug2022, the device was under evaluation at the imi facility.It was unknown about the alarm code.The date of event occurred was 08aug2022.The second device was used.Per follow-up information received via email on 16aug2022, the only information available was that the system was temporarily interrupted for inspection while a patient was using it, and when it was restarted afterward, the water flow did not flow, and an alarm sounded.There was no detailed information about the alarm.The device was used on the patient, but no impact to the patient.

• Brand Name: ARCTIC SUN® 5000
• 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: 15282466
• MDR Text Key: 305248449
• Report Number: 1018233-2022-06633
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• 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
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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