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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 Overheating of Device (1437); Use of Device Problem (1670); Overfill (2404)
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 arctic sun device was received in the biomed department with a note that said it was not warming the patient, gave an alert 113, and the device was swapped. The biomed had the device running with the water temperature at 5c. Per troubleshooting with ms&s, the device was placed in manual control with a water target of 42c. The water was slow to heat. The water level was showing full, so the biomed was instructed to drain 500ml from the circulation tank. The water temperature then rose to 39c before manual control was stopped. Per a follow up call with the nurse (b)(6), on (b)(6) 2019, the patient temperature had dropped to 31-32c and the water temperature was not increasing to get the patient back up to the target temperature. The device was swapped and the patient was able to complete therapy on a second device. She stated that the pads had not been drained before filling the device, which caused the overfill.
 
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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 Key8271367
MDR Text Key134073863
Report Number1018233-2019-00398
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/23/2019
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 Received01/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2017
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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