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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 Device Sensing Problem (2917); Appropriate Term/Code Not Available (3191)
Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)
Event Type  Injury  
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 arcticsun device was displaying an alert 113 (reduced water temperature control) during therapy. The target temperature was 33c, the patient's temperature was 37c, the water temperature was 7. 5c, the flow rate was 2. 4l/min, the trend was neutral, and the mixing pump command was 100%. The nurse stated that the patient was sedated, but not paralyzed. There were no signs of shivering or seizing, but the nurse could not determine if the jaw felt relaxed. Per troubleshooting, the nurse was advised to leave the patient on the device and to add a universal pad to the exposed abdomen. Causes of heat generation and counter warming were also discussed. The nurse was called back two hours later. A universal pad and a blanket had been added, and the patient was trending down with a temperature of 36. 4c. The water was 7. 3c, but another alert 113 was displayed. Per call back on 13nov2019, the device also received an alert 116 ( patient temperature 1 change not detected). The device was responding appropriately and ms&s suggested diligent skin checks.
 
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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 Key9382536
MDR Text Key168573716
Report Number1018233-2019-07589
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741127755
UDI-Public(01)00801741127755
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 01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
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 Received01/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2018
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: 11/27/2019 Patient Sequence Number: 1
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