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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 Display or Visual Feedback Problem (1184); Restricted Flow rate (1248); No Flow (2991)
Patient Problems No Known Impact Or Consequence To Patient (2692); 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 there was no flow on the arctic sun device. The nurse trying to start the therapy on the patient and getting an alert 01 (patient line open) and an alert 02 (low flow). Ms&s walked through the proper disconnect and reconnect of the arctic gel pads. The large size arctic gel pads were in use. In normothermia, the patient temperature was 40. 7c, the target temperature was 37c and the rewarm rate was 0. 25c/hr. The system diagnostics showed that the water flow rate was 0 l/m with -0. 3 psi and the circulation pump command was 100%. In manual mode with arctic gel pads at 10c, the patient was 40. 6c, the outlet monitor temperature ( t1) was 7. 5c, the outlet control temperature (t2) was 7. 5c, the inlet temperature (t3) was 24. 6c, the chiller temperature (t4) was 4. 8c, the water flow rat was 0, the inlet pressure was -0. 1 psi, the circulation pump command was 100%, the mixing pump command was 0, the system hours were 2113. 1 and the pump hours were 1628. Ms&s advised to send the arctic sun device to biomed. Per follow up via biomed on 11sep2020, the biomed did a preventative maintenance and the calibration on the arctic sun device and would not find an issue with it. The arctic sun device was put back in service.
 
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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 Key10570491
MDR Text Key208561015
Report Number1018233-2020-06139
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 03/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2020
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 Received03/04/2021
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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