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

Model Number 50000000

Device Problem Overheating of Device (1437)

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

Event Date 03/13/2021

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 repeatedly failed calibration for an error 81 (non-recoverable system error).Checked the ctu was in calibration and stated it was able to calibrate other devices without issue.And stated this could be an issue either with one of the thermistors or the i/o board and recommended he returned the device for an assessment.Per evaluation findings, the hot connection from the power inlet module to the ac main voltage card shows signs of electrical overstress.Both module and card will need replaced.

Manufacturer Narrative

The reported issue was confirmed by capa association as manufacturing related.The root cause in capa are: the overheating of the wires was assessed by the investigation tasks and used to complete the root cause evaluation using the fishbone methodology.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.The neutral connection between the power inlet module and the ac main voltage circuit card shows signs of electrical overstress.Both module and card will need replaced.All other upgrades were verified complete in accordance with service procedures.The arctic sun 5000 passed all performance testing, calibration, and electrical safety tests.The unit is ready for use.The device history record and labeling review was not required as the complaint addressed by existing capa.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 actual/suspected device was inspected.

Event Description

It was reported that the arctic sun device repeatedly failed calibration for an error 81 (non-recoverable system error).Checked the ctu was in calibration and stated it was able to calibrate other devices without issue and stated this could be an issue either with one of the thermistors or the i/o board and recommended he returned the device for an assessment.Per evaluation findings, the hot connection from the power inlet module to the ac main voltage card shows signs of electrical overstress.Both module and 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
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11620414
• MDR Text Key: 243982542
• Report Number: 1018233-2021-01913
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• 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: 09/22/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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