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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 Display or Visual Feedback Problem (1184); Failure to Pump (1502); Temperature Problem (3022)
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 the arctic sun device had an alert 113 (reduced water temperature control). The target temperature was 37c, the patient temperature was 39c, the water temperature was 29c, the flow rate was 2. 9 l/min. There was an adequate arctic gel pad coverage. The patient has been on therapy for approximately 3 hours. System diagnostic showed that the outlet monitor temperature (t1) was 29. 2c, the outlet control temperature (t2) was 29. 2c, the chiller temperature (t4) was 4. 6c, the flow rate was 3l/min, the circulation pump command was 80%, the mixing pump command was 100%, the system hours were 5370. 3 and the pump hours were 4514. 9. Informed that the mixing pump might need further troubleshooting and recommended changing out the arctic sun device. Nurse stated that they had a second device and was able to switch it out. The nurse would call back if needed. Advised to label this arctic sun device as alert 113 (reduced water temperature control) and send to biomed for further troubleshooting.
 
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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 Key10600626
MDR Text Key214152173
Report Number1018233-2020-06247
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 03/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2015
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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