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

Catalog Number 5000-01-02

Device Problem Power Problem (3010)

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

Event Date 10/28/2021

Event Type  malfunction  

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 did not rewarm while treating the patient.The patient passively rewarmed and was not controlled by the device.As per follow up information received on 28 oct 2021, the representative could not see any evidence in relation to arctic sun device if it was not automatically rewarming after 24 hours at target temperature.The user assumed that the normothermia mode had been selected rather than the hypothermia mode, and the target temp was adjusted to 36 degrees.Therefore, considering that this mode would not rewarm after 24 hours.It would also appear that on certain instances the therapy had been stopped earlier than 24 hours, prior to when the device would be automatically rewarmed.From reviewing the data, the user believed that the additional training was required.

Manufacturer Narrative

The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be incorrect settings.However, this cannot be confirmed.It is unknown if the device met specifications or was influenced by the reported failure.The device was in use on a patient.A device history review is not required as the serial number is unknown.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 (50°f); control strategy = 2.It is recommended to use the patient temperature high and patient temperature low alert settings.Initiate normothermia (control patient & rewarm patient) normothermia therapy is initiated and managed, and patient temperature is automatically controlled to a set target temperature from the control patient window in the normothermia therapy screen.The control patient window displays the patient target temperature and the duration since the initiation of normothermia therapy.To initiate normothermia therapy: 1) from the patient therapy selection screen, press the normothermia button to display the normothermia therapy screen.2) the default patient target temperature will display in the control patient window.3) to modify the patient target temperature, press the adjust button to display the control patient-adjust window.4) control patient to: use the up and down arrows to set the desired patient target temperature to control the patient.5) rewarm at a rate of: use the up and down arrows on the right of the screen to set the rewarming rate.6) press the save button to save the new settings and close the control patient-adjust window 7) press start, in the control patient window to initiate therapy.You will hear a tone and then a voice stating ¿therapy started¿.Additionally, the control patient window and the arctic sun® temperature management system icon will blink, indicating that therapy is in progress.Initiate hypothermia (cool patient and rewarm patient) hypothermia therapy is initiated and managed, and patient temperature is automatically controlled to a set target temperature from the cool patient and rewarm patient windows in the hypothermia therapy screen.The cool patient window displays the cooling phase patient target temperature and the length of time remaining in the cooling phase of the hypothermia therapy.The rewarm patient window displays the rewarming phase patient target temperature and the length of time remaining in the rewarming phase of the hypothermia therapy.To initiate hypothermia therapy: from the patient therapy selection screen, press the hypothermia button to display the hypothermia therapy screen.1.Cool patient settings ¿ the default patient target temperature and duration will display in the cool patient window.¿ ¿ to modify the patient target temperature and duration, press the adjust button to display the cool patient-adjust window.¿ cool patient to: use the up and down arrows on the left side to set the desired patient target temperature to cool the patient ¿ cool patient for: use the up and down arrows on the right side to set the cooling duration to cool the patient before rewarming begins.¿ press the save button to save the new settings and close the cool patient-adjust window" the device was not returned.

Event Description

It was reported that the arctic sun device did not rewarm while treating the patient.The patient passively rewarmed and was not controlled by the device.As per follow up information received on 28oct2021, the representative could not see any evidence in relation to arctic sun device if it was not automatically rewarming after 24 hours at target temperature.The user assumed that the normothermia mode had been selected rather than the hypothermia mode, and the target temp was adjusted to 36 degrees.Therefore, considering that this mode would not rewarm after 24 hours.It would also appear that on certain instances the therapy had been stopped earlier than 24 hours, prior to when the device would be automatically rewarmed.From reviewing the data, the user believed that the additional training was required.

• 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: 12868720
• MDR Text Key: 283181764
• Report Number: 1018233-2021-07513
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5000-01-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• 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