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

Model Number 50000000

Device Problem No Display/Image (1183)

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

Event Date 11/22/2022

Event Type  malfunction  

Event Description

It was reported that the nurse was using arctic sun device to cool patient.Device was plugged into the bed.Nurse went to check temperatures for charting and when tried to restart therapy the screen went blank, made a loud beeping noise and sounded like it was running.Unplugged and plugged into the wall outlet.Restarted therapy, stopped therapy shortly after that to document and device powered off again with blank screen, but sounded like it was on.Device was on now with no additional issues, but did alert that there was only enough water for one patient.Nurse wanted to know if they should continue using.Mis explained the initial power loss was likely due to the device being plugged into the bed.However since it has done it again since being plugged into the wall and they have another device available for use, it would not be a bad idea to send to biomed to have it evaluated.Noted that alert regarding water level was likely due to the pads no being emptied when the device powered off.Nurse was in office and did not have serial number available.Mis advised biomed could call the same number tomorrow if assistance needed from engineering.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Manufacturer Narrative

Upon further review, bd has determined that this mdr is not reportable.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 device was not returned.

Event Description

It was reported that the nurse was using arctic sun device to cool patient.Device was plugged into the bed.Nurse went to check temperatures for charting and when tried to restart therapy the screen went blank, made a loud beeping noise and sounded like it was running.Unplugged and plugged into the wall outlet.Restarted therapy, stopped therapy shortly after that to document and device powered off again with blank screen, but sounded like it was on.Device was on now with no additional issues, but did alert that there was only enough water for one patient.Nurse wanted to know if they should continue using.Mis explained the initial power loss was likely due to the device being plugged into the bed.However since it has done it again since being plugged into the wall and they have another device available for use, it would not be a bad idea to send to biomed to have it evaluated.Noted that alert regarding water level was likely due to the pads no being emptied when the device powered off.Nurse was in office and did not have serial number available.Mis advised biomed could call the same number tomorrow if assistance needed from engineering.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15939354
• MDR Text Key: 307954446
• Report Number: 1018233-2022-09390
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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