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

Catalog Number 50000000

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 06/28/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 biomed stated they had a arctic sun device, that had no flow when performing a functional check.Then another biomed had taken the back panel off while device was running in therapy and noticed that one of the solenoids were not moving.The biomed was able to hit it with a wrench and get it to move, however when they tried performing another functional check, the same solenoid is not moving again.The biomed wanted to troubleshoot to see if there was a way to repair or replace just the one part.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found that there was no allegation against product.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 biomed stated they had a arctic sun device, that had no flow when performing a functional check.Then another biomed had taken the back panel off while device was running in therapy and noticed that one of the solenoids were not moving.The biomed was able to hit it with a wrench and get it to move, however when they tried performing another functional check, the same solenoid is not moving again.The biomed wanted to troubleshoot to see if there was a way to repair or replace just the one part.

• 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: 17350211
• MDR Text Key: 320161450
• Report Number: 1018233-2023-05287
• Device Sequence Number: 1
• Product Code: DWJ
• 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: 08/02/2023

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 Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/19/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/02/2023
• 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