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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 50000000E
Device Problems Insufficient Cooling (1130); Display or Visual Feedback Problem (1184)
Patient Problems Unspecified Infection (1930); 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 arctic sun device received an alert 52 (extended period of cold water). The cooling was started 6 hours ago. The target temperature was 33c. The patient temperature was 36. 1c at the start of the call by the end it was 36c. The water temperature was 5c and the flow rate was 3. 1 l/m. The 5 pads were in good coverage. The esophageal probe in place. The second temperature source correlating and the bair hugger in place, according to the protocol. On a low setting no shivering was noted, according to the nurse. The trend was in middle at the start of the call, 1 bar down. The nurse checked the patient's skin and appears to be fine. The nurse explained the machine was doing what it should be. The nurse will speak to the doctor regarding the infection and possibly will start the (b)(4). Ms&s instructed the nurse to call back when the alarm goes off again or for any other issues. The nurse was aware of the possible skin issues when the water was too low for too long.
 
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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 Key10619774
MDR Text Key215114377
Report Number1018233-2020-06302
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 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
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 Received03/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2018
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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