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

Catalog Number 5000-01-01

Device Problems Filling Problem (1233); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 had an issue filling with water.The patient was switched to a different device to complete therapy.

Event Description

It was reported that the arctic sun had an issue filling with water.The patient was switched to a different device to complete therapy.

Manufacturer Narrative

The reported issue was confirmed.No root cause necessary as per the attached email from sales, it was user related.The device was working well upon evaluation.It is undetermined what the user did or did not do, although the user will be retrained by the sales representative.No repairs were necessary as the device was functioning appropriately.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: "1) fill the reservoir with serile or distilled water only.2) four liters of water will be required to fill the reservoir at initial installation.3) add one fvial of arctic sun temperature management system cleaning solution to the sterile or distilled 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.

• Brand Name: ARCTICSUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 9853038
• MDR Text Key: 186318431
• Report Number: 1018233-2020-01907
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5000-01-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 77