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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 Problems Break (1069); Insufficient Cooling (1130); Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the patient was not cooling as expected while on the arctic sun device. The patient was a cardiac arrest patient who arrived with fever of 40c. The patient's temperature was 38. 4c at the time of the call. The water temperature was 21. 1c and the flow rate was 2. 2 l/m. The target temperature was 36c, cooling over the next 24 hours. Large patient with large arctic gel pads and only a very small amount of exposed abdomen but nurse stated that not enough to need a universal pad. The arctic device was receiving an alert 113 ( reduced water temperature control). The outlet monitor temperature (t1) was 20. 9c, the outlet control temperature (t2) was 20. 8c, the inlet temperature (t3) was 21. 2c, the chiller temperature (t4) was 20. 7c, the water flow rate was 2. 2 l/m, the inlet pressure was -7 psi, the circulation pump command was 57%, the mixing pump command was 100%, heater 0, the system hours was 1389. 5 and the pump hours 1231. 5. The nurse placed arctic sun device in manual mode at 5c and ran for about 15 minutes. The outlet monitor temperature (t1) was 20. 8c, the outlet control temperature (t2 ) was 20. 8c, the inlet temperature (t3) was 21. 1c, the chiller temperature (t4) was 20. 7c, the inlet pressure was -7psi, the circulation pump command was 57%, the mixing pump command was 100%. Explained mixing pump appears to be broken and send to biomed with note of alert 113 (reduced water temperature control). Mss asked if another arctic sun device was available. Nurse called emergency department (ed) and the icu already has their arctic sun device. No other arctic sun device was available. Nurse asked if could send loaner unit. Mss responded nurse to contact biomed to coordinate repair and loaner shipment. Per follow up via nurse on (b)(6) 2020, patient completed therapy on second arctic sun device and the first arctic sun device was sent to biomed.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC SUN DEVICE
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 Key10495176
MDR Text Key206961837
Report Number1018233-2020-05717
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 health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2020
Is this an Adverse Event Report? No
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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