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

Model Number 50000000

Device Problems Circuit Failure (1089); Overheating of Device (1437)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2020

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 as per evaluation of arctic sun device, the neutral connection between the power inlet module and the ac main voltage circuit card shows signs of electrical overstress.Both the module and circuit card will need replaced.

Manufacturer Narrative

The reported issue was confirmed by capa association as manufacturing related.The root cause of the reported issue was covered in capa.The neutral connection between the power inlet module and the ac main voltage circuit card shows signs of electrical overstress.Both the module and circuit card were replaced.All upgrades were verified complete in accordance with service procedures.The arctic sun 5000 passed all performance testing, calibration and electrical safety tests and is functioning properly and ready for use.It was concluded that the following was the root cause: supplier ¿ root cause : inadequate verification and validation activities of the crimping process, single pull test did not provide stability of process, evidence was not provided when requested for maintenance of records or crimp tools, no crimp cross-sections provided.Complaint addressed by existing capa; therefore, the device history record and labeling review was not performed.The actual/suspected device was inspected.

Event Description

It was reported that as per evaluation of arctic sun device, the neutral connection between the power inlet module and the ac main voltage circuit card shows signs of electrical overstress.Both the module and circuit card will need replaced.

• 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
• MDR Report Key: 10756239
• MDR Text Key: 213704289
• Report Number: 1018233-2020-20564
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (y/n): N
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• 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
• Date Returned to Manufacturer: 09/24/2020
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other