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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 500 ARCTICSUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 500 ARCTICSUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Unexpected Therapeutic Results (1631); Device Sensing Problem (2917)
Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)
Event Type  malfunction  
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 was rewarming on the arcticsun device when the patient's temperature began to drop. There had been an alarm 15 (unable to obtain stable pt temp) and an alert 51 (pt temp one below control range). The patient's temperature was 30. 8c with a target temperature of 36. 4c. There was a foley probe in place and the trend indicator was in the middle. The flow rate was 2. 3l/min and the water temperature was 42c. The nurse stated that the patient's vitals were within normal limits. Per troubleshooting, the nurse checked the cable and foley placement. The nurse was advised to swap out the device, and if the alarms return to replace the foley temp probe. Per follow up with the nurse via phone on 03jun2019, the device was swapped. Per the msicu nurse via phone on 03jun2019, the patient and the device were no longer in the unit.
 
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Brand NameARCTIC SUN 500
Type of DeviceARCTICSUN 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 Key8713775
MDR Text Key150858782
Report Number1018233-2019-03223
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
Type of Report Initial,Followup
Report Date 07/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2010
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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