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 03/22/2022

Event Type  malfunction  

Event Description

It was reported that the patient temperature was not displayed on the arctic sun device.Then the temperature was maintained, the patient's temperature was displayed but it was confirmed the water temperature did not drop.System hours were unknown and pump hours were 5879.The device would be evaluated at the imi facility.Per follow up information received on 24mar2022, customer used a second device and the first device was investigated at imi facility.

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

The reported issue was unconfirmed.The root cause was not able to be determined as the reported issue was not duplicated during evaluation.The device was evaluated and the reported issue was unconfirmed as the patient's temperature was able to display during testing.No repairs for reported issue were made.The water temperature did not drop.Mixing pump replaced.Calibration and function checked.Arctic sun passed all tests successfully and unit is ready to be returned to the customer.It was unknown if the device was influenced by the reported failure, however the device met specifications during evaluation.The device was in use on a patient.The device history record review was not required as the reported event was unconfirmed.The labeling review was not required as the reported event was unconfirmed.The actual/suspected device was inspected.

Event Description

It was reported that the patient temperature was not displayed on the arctic sun device.Then the temperature was maintained, the patient's temperature was displayed but it was confirmed the water temperature did not drop.System hours were unknown and pump hours were 5879.The device would be evaluated at the imi facility.Per follow up information received on 24mar2022, customer used a second device and the first device was investigated at imi facility.

• 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: 14120332
• MDR Text Key: 289429864
• Report Number: 1018233-2022-02552
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/31/2022

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: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 08/31/2022
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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