MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTIC GEL PADS

Catalog Number 50000000E

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Myocardial Infarction (1969); Respiratory Distress (2045); Seizures (2063); Sepsis (2067); Skin Discoloration (2074); Skin Irritation (2076); Diabetic Ketoacidosis (2364); Meningitis (2389); Burn, Thermal (2530)

Event Date 01/30/2019

Event Type  Injury  

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 a patient allegedly experienced frostbite to his bilateral lower extremities during arctic sun therapy. A physician placed a call to the ms&s helpline on (b)(6) 2019 at 2:23 pm to report that he had a patient with peripheral vascular disease on normothermia who developed frostbite. He also stated that the patient was no longer on the device during the time of the call. On (b)(6) 2019, it was reported via email from (b)(6), stating that the patient expired unrelated to the device. The patient was placed on the arctic sun device on (b)(6) 2019 due to hyperthermia. Skin assessments were performed every four hours on the patient. On (b)(6) 2019, blisters and a mottled appearance were noted on the patient¿s thighs bilaterally and on the right knee, and mepilex dressings were applied to the affected areas. The patient weighed (b)(6) and a set of large pads were in use. The water temperature ranged from 4. 7c to 41. 9c during therapy. The cause of death is unknown at this time; however, the facility stated that the patient expired unrelated to the device. The patient was found unresponsive and admitted to the hospital with seizures, myocardial infarction, bacterial meningitis, sepsis, respiratory failure, positive posturing, rhabdomyolysis, and diabetic ketoacidosis. The device was evaluated and passed the functional check and then returned to service.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8355217
• MDR Text Key: 136732622
• Report Number: 1018233-2019-00896
• Device Sequence Number: 1
• Product Code: DWJ
• 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: company representative,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 02/20/2019 Patient Sequence Number: 1