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

Model Number 50000000

Device Problems Insufficient Heating (1287); Use of Device Problem (1670)

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

Event Date 05/12/2021

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 a reheat time was programmed in the arctic sun device and during that time it was not possible for the equipment to reach the expected heat.Per follow up with ibc on 31may2021, the therapy was discontinued because of the issue.

Event Description

It was reported that a reheat time was programmed in the arctic sun device and during that time it was not possible for the equipment to reach the expected heat.Per follow up with ibc on 31may2021, the therapy was discontinued because of the issue.

Manufacturer Narrative

The reported issue was confirmed.The root cause for the reported issue was that the user was incorrectly configuring the therapy.Per follow up, it was found that the user was incorrectly configuring the therapy and the equipment was working properly.All good faith attempts have been made to obtain additional information.The outcome of the repair could not be determined at this time.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: "cautions: the clinician is responsible to determine the appropriateness of custom parameters.When the system is powered off, all changes to parameters will revert to the default unless the new settings have been saved as new defaults in the advanced setup screen.For small patients (=30 kg) it is recommended to use the following settings: water temperature high limit =40°c (104°f); water temperature low limit =10°c (64.4 °f); control strategy =2.2.Rewarm patient settings the default patient target temperature and duration will display in the rewarm patient window.To change the rewarming phase patient target temperature and rewarming rate, press the adjust button in the rewarm patient window to display the rewarm patient-adjust screen.Use the up and down arrows on the left side to set the desired final patient target temperature.Rewarm patient to: use the up and down arrows on the right side to set the desired final patient target temperature.Rewarm at a rate of: use the up and down arrows in the center of the screen to set the rewarming rate.Rewarm patient from: when cooling a patient, adjustment of the rewarm patient from setting on the left side of the screen is disabled and defaults to the cool patient target temperature.When rewarming a patient, the rewarm patient from adjustment is enabled and the value can be modified.The rewarm patient from setting is the temperature to which the system is currently controlling the patient.The rewarm patient from temperature will automatically increase as the rewarming process continues.This feature allows the rewarming procedure to be optimized by allowing complete control of the rewarming ramp.Using the rewarm patient from temperature, the rewarm patient to temperature and the rewarming rate settings, the system will calculate and display the rewarming duration and the date/time at which the patient will reach the final rewarming target temperature.Press the save button to save the new settings and close the rewarm patient-adjust window." 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: 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: 11948402
• MDR Text Key: 254630181
• Report Number: 1018233-2021-03279
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• 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: 5000-01-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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