MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTIC GEL PADS

Catalog Number 317-09-02

Device Problem Biocompatibility (2886)

Patient Problem Skin Discoloration (2074)

Event Date 02/12/2022

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 patient was maintaining normothermia on the arctic sun device.The patient did have mottling all over their body, but now it just localized under the arctic gel pads themselves.Patient had a long downtime which was greater than 1.5 hours and had a poor prognosis.Currently patient temperature was 36.8c and water temperature was 23.3c.Nurse wanted to know whether to remove the pads.Mss suggested consulting with doctor on whether to remove the pads at this time and advised to pay attention on water temperature and be cautious of high and low water temperatures.Mss also explained that the patient might be able to maintain normothermia without therapy running at this point.No medical intervention was reported.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event 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 patient was maintaining normothermia on the arctic sun device.The patient did have mottling all over their body, but now it just localized under the arctic gel pads themselves.Patient had a long downtime which was greater than 1.5 hours and had a poor prognosis.Currently patient temperature was 36.8c and water temperature was 23.3c.Nurse wanted to know whether to remove the pads.Mss suggested consulting with doctor on whether to remove the pads at this time and advised to pay attention on water temperature and be cautious of high and low water temperatures.Mss also explained that the patient might be able to maintain normothermia without therapy running at this point.No medical intervention was reported.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Type of Device: ARCTIC GEL PADS
• 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: 13692917
• MDR Text Key: 286772496
• Report Number: 1018233-2022-01107
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• 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: 03/11/2022

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 Expiration Date: 02/28/2023
• Device Catalogue Number: 317-09-02
• Device Lot Number: NGFP3582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 02/12/2022
• Supplement Dates FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other