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

Model Number 50000000

Device Problems Use of Device Problem (1670); Missing Information (4053)

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

Event Date 11/10/2020

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 once the water temperature was set before the operation started on the arctic sun device , it could not be changed during operation.After changing the default settings, the arctic sun device needs to be rebooted.Per additional information received, if only pre-condition water temperature was changed, the arctic sun device setting could not be effective and required default of advanced update.The hospital pointed out to imi that this matter of procedure need to be described more carefully to understand.Per reviewing with technical support, the facility believes that there was an inadequate instructions in the manual regarding pre-conditioned water temperature.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue could be determined and isolated to user related.It was found that the customer was not aware of the water temperature should not be changed before starting the therapy when the water temperature before therapy is enable.No repairs performed as the unit was working appropriately.After changing the default settings, the arctic sun device needs to be rebooted.Per additional information received, if only pre-condition water temperature was changed, the arctic sun device setting could not be effective and required default of advanced update.The unit was working fine.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿fill reservoir 1) fill the reservoir with sterile water only.2) four liters of water will be required to fill the reservoir at initial installation.3) add one vial of arctic sun® temperature management system cleaning solution to the sterile water.4) from the patient therapy selection screen, press either the normothermia or hypothermia button, under the new patient heading.5) from the hypothermia or normothermia therapy screen, press the fill reservoir button.6) the fill reservoir screen will appear.Follow the directions on the screen.¿ 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 actual/suspected device was inspected.

Event Description

It was reported that once the water temperature was set on the arctic sun device before the operation, it could not be changed during operation.After changing the default settings, the arctic sun device needs to be rebooted.Per additional information received, if only pre-condition water temperature was changed, the arctic sun device setting could not be effective and required default of advanced update.The hospital pointed out to imi that this matter of procedure needs to be described more carefully to understand.Per reviewing with technical support, the facility believed that there was an inadequate instruction in the manual regarding pre-conditioned water temperature.

• 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: 10952770
• MDR Text Key: 221275749
• Report Number: 1018233-2020-21405
• 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: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• 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: 11/06/2020
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other