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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 Insufficient Heating (1287); Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2022
Event Type  malfunction  
Event Description
It was reported that the hypothermia patient at 36 c was rewarming on arctic sun device for 3 hours and the nurse felt the device was not making water hot enough to warm the patient. The patient temperature was 34. 9 c, water temperature was 27 c, flow rate was 2. 8 l/min and there was good pad coverage. The patient came in with a temperature in the range of 34 c range and not under crrt (continuous renal replacement therapy). The device was in normothermia mode and the nurse had just changed the target from 36 c to 37 c and changed the rewarm rate to maximum. The water temperature was now up to 39 c. Mss discussed about the dangers of fast warming. Nurse decided it would be best to restart warming/therapy under hypothermia mode. Mss walked nurse through setting device to rewarm from 35 c at 0. 25 c/ hour to 36c , which was their protocol rewarm rate. Mss recommended nurse to not keep changing the settings but call first if needed any assistance. The device could make warm water and it was responding appropriately to the changes in the patient temperature.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
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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
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13448095
MDR Text Key287343913
Report Number1018233-2022-00389
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 Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2022
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
Date Manufacturer Received06/07/2022
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: 02/03/2022 Patient Sequence Number: 1
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