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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 5000 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Device Alarm System (1012); Insufficient Cooling (1130); Device Sensing Problem (2917)
Patient Problems Alteration In Body Temperature (2682); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that the patient's temperature overshot the target temperature to 30. 3c. The water temperature was 40c. The patient had been administered sedation prior to the overshoot. The event log had showed multiple alert 113 (reduced water temperature control). The complainant noted she would switch the patient to a second device.
 
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Brand NameARCTICSUN 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 Key9671857
MDR Text Key178122882
Report Number1018233-2020-00720
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2020
Is this an Adverse Event Report? Yes
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 Received03/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2013
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: 02/05/2020 Patient Sequence Number: 1
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