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

Model Number 50000000

Device Problem No Display/Image (1183)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2022

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 was on, but the screen was blank.Mis advised that they need to swap out to a different device and send to biomed for repair.As per follow-up information, received via email on 15dec2022, biomed told nurse that it repeated booted to an alarm 47 (control panel communication).They discussed that they would need to investigate further to isolate the problem to the control panel, wiring, or the processor card.Biomed stated that they would replace the part once they determined the root cause.

Manufacturer Narrative

Upon further review, bd has determined that this event is not reportable.H11: section a through f - the information provided by bard represents all of 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 bard.H3 other text: the device was not returned.

Event Description

It was reported that the arctic sun device was on, but the screen was blank.Mis advised that they need to swap out to a different device and send to biomed for repair.As per follow up information received via email on 15dec2022, biomed told nurse that it repeated booted to an alarm 47 (control panel communication).They discussed that they would need to investigate further to isolate the problem to the control panel, wiring, or the processor card.Biomed stated that they would replace the part once they determined the root cause.Per follow up information received via phone on 29dec2022, biomed stating that they had replaced the control panel, but they tried to fill the device and device was leaking out of the front per email response received from technician support and biomed communication on 30dec2022, biomed did not add the cleaning solution when refilling, so they overfilled the tank.Per review of wo on 01jan2023, there was no patient involvement.

• 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: 16067959
• MDR Text Key: 307726409
• Report Number: 1018233-2022-09977
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/10/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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