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

Model Number 50000000

Device Problem Computer Operating System Problem (2898)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2020

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 the arctic sun device flow rate was only 1.5 l/min.Another arctic pad was used, but the problem was not resolved.Both arctic gel pad was found to be expired.After confirming that there was no bending, changed to another pad but the symptom did not changed.In addition, alarm 80 occurred (non-recoverable system error) and the main unit was restarted and used.The arctic sun device was returned to imi for investigation of arctic gel pad failure.

Event Description

It was reported that the arctic sun device flow rate was only 1.5 l/min.Another arctic pad was used, but the problem was not resolved.Both arctic gel pad was found to be expired.After confirming that there was no bending, changed to another pad but the symptom did not changed.In addition, alarm 80 occurred (non-recoverable system error) and the main unit was restarted and used.The arctic sun device was returned to imi for investigation of arctic gel pad failure.Per follow up via ibc on 16feb2021, the device was sent to imi for investigation.The arctic sun device was visually inspected upon receipt and was found to be in good condition.The main body does not have a fault and arctic gel pad replacement was performed.No trouble shooting performed.

Manufacturer Narrative

The reported issue was unconfirmed.The root cause of the reported issue could not be determined as the reported issue could not be reproduced.The device was working properly.It was found that the main body does not have a fault.No repairs were made to the unit.Calibration and function check was performed.The device history record review was not required as the reported event was unconfirmed.The labeling review is not required as the reported issue was unconfirmed.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.H3 other text : the actual/suspected device was inspected.

• 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: 11055187
• MDR Text Key: 223138408
• Report Number: 1018233-2020-21886
• 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: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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: 11/27/2020
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other