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

Model Number 50000000

Device Problems Material Fragmentation (1261); Defective Component (2292)

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

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that biomed had an arctic sun device in which the isolation card was damaged.Mss provided part number and price.Biomed stated that they would order a replacement and replace onsite.Per follow up information received on 05aug2022, biomed would be repairing device onsite, it was unknown how the isolation circuit card was was damaged.Per tech support it was not uncommon for this sort of damage it could be based on how temperature cables were connected or disconnected.No patient involvement.

Manufacturer Narrative

The reported issue was confirmed.The device was not returned.The root cause of the reported issue was isolated to damaged isolation card.Per tech support it was not uncommon for this sort of damage it could be based on how temperature cables were connected or disconnected.Biomed stated that they would order a replacement and replace onsite.Per additional information received, biomed would be repairing device onsite, it was unknown how the isolation circuit card was damaged.It is known that the device did not meet specifications and whether the device was influenced by the reported failure.There was no patient involvement.The device history record review was not required as event was not an out of box failure.The labeling review was 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 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 bd.H3 other text : the device was not returned.

Event Description

It was reported that biomed had an arctic sun device in which the isolation card was damaged.Mss provided part number and price.Biomed stated that they would order a replacement and replace onsite.Per follow up information received on 05aug2022, biomed would be repairing device onsite, it was unknown how the isolation circuit card was was damaged.Per tech support it was not uncommon for this sort of damage it could be based on how temperature cables were connected or disconnected.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: 15224676
• MDR Text Key: 304003280
• Report Number: 1018233-2022-06362
• 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: 01/25/2023

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: 08/02/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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