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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problem Insufficient Cooling (1130)
Patient Problems Sepsis (2067); Convulsion/Seizure (4406)
Event Date 05/03/2022
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 the patient was in normothermia mode in the arctic sun device. Nurse stated that the therapy had stopped due to continuous alerts for prolonged cold water exposure alert 52 (extended period of cold water) and alarm 53 (prolonged cold water exposure). Nurse stated that the patient temperature was 37. 6c, target temperature was 37c, water temperature was 5c when nurse noted, and flow rate was 2. 9lpm and patient weighs about 121kg. Patient had a set of large pads in place, no universal pad over the belly of the patient. Mss advised the nurse to add a universal pad to abdomen as the water temperature was staying very low to compensate for the inadequate pad coverage on this patient. Mss advised to perform a diligent and careful skin checks on this patient. Mss inquired about other causes of heat generation. Nurse stated there were issues with seizure activity that had been resolved. A sepsis work up was also being done. Mss explained that the machine would continue to make cold water and alarm if the heat generation was not addressed.
 
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Brand NameARCTIC SUN® 5000
Type of DeviceARCTIC 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 Key14487650
MDR Text Key292493335
Report Number1018233-2022-04028
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
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 Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2012
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: 05/24/2022 Patient Sequence Number: 1
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