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

Model Number 50000000E

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 08/15/2022

Event Type  malfunction  

Event Description

It was reported that the arctic sun device was getting an error message about low flow, so they powered the device off.Now device was saying that the reservoir was empty.Mss walked nurse through emptying and disconnecting the arctic gel pads.Nurse stated when they went to fill the device it was full and spilling back out.Mss determined the fill tube was in the drain port and discussed proper placement of the fill tube.The room was full of providers.Nurse would call back if the flow was low when they resume therapy and discussed how to properly connect the pads.

Manufacturer Narrative

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

Event Description

It was reported that the arctic sun device was getting an error message about low flow, so they powered the device off.Now device was saying that the reservoir was empty.Mss walked nurse through emptying and disconnecting the arctic gel pads.Nurse stated when they went to fill the device it was full and spilling back out.Mss determined the fill tube was in the drain port and discussed proper placement of the fill tube.The room was full of providers.Nurse would call back if the flow was low when they resume therapy and discussed how to properly connect the pads.Per follow up information received on 30aug2022, patient was able to complete therapy on same device with no further issues after help from mss.

Manufacturer Narrative

Per additional information received, bd has determined that this mdr event is not reportable.The device was not returned.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15301169
• MDR Text Key: 303314716
• Report Number: 1018233-2022-06674
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• 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: 09/13/2022

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: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 08/30/2022
• Supplement Dates FDA Received: 09/14/2022
• 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