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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTIC GEL PADS Back to Search Results
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.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC 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 Key8355217
MDR Text Key136732622
Report Number1018233-2019-00896
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
Number of Events Reported1
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 Received02/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number50000000E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
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
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