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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 Inadequacy of Device Shape and/or Size (1583); Device Sensing Problem (2917); Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 water temperature had been stable around 36. 1c during normothermia therapy on the arctic sun device, but then suddenly spiked to 41. 6c. The water temperature then went back down, so they changed devices. The second device did the same thing. There was a foley probe in use. Per troubleshooting with ms&s, the nurse denied there being any alerts/alarms but was not in the room at the time to look at the event log. Ms&s suggested troubleshooting the foley probe if the temperature becomes erratic again. They had changed the pads previously that day to size medium. The pads were too small, so a universal pad was added. Ms&s explained this should not cause a sudden change in water temperature. Per additional information received via phone on (b)(6) 2019 with the biomed technician, the first device was received in biomed where it was ran for several hours with a temp probe and pads. He stated that he also placed the device in manual mode to confirm functionality and found no issues with the device. The temperatures did not read erratic during his evaluation.
 
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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 Key8514510
MDR Text Key142611843
Report Number1018233-2019-01951
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
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 05/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2019
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 Received05/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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