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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS ARCTIC GEL PADS

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS ARCTIC GEL PADS Back to Search Results
Catalog Number 318-02
Device Problems Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182); Gas Leak (2946)
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.
 
Event Description
It was reported that there was low flow on the arctic sun device. The patient was cooling when the arctic sun device alerted "low flow, air leak" the nurses stopped the blanket, emptied that water, disconnected and reconnected the arctic gel pads then restarted. After a minute, they received the same alert again. The user repeated the troubleshooting 3 times and there was no change. The user found no cracks or issue with the arctic gel pads and stated there was adequate water in the system. The nurse stated their pads have a - and + instead of the blue and white marks, so they tried connecting of all ways to see if it would resolve the issue but it did not. They got a new arctic gel pad and connected it to the same device but they got the same alert. The user got a new machine and connected it to the second set of arctic gel pads and it started to function fine with no alerts and have saved the neonatal pads for return. Per follow-up on 06aug2020, it was reported that the patient completed therapy on the second device.
 
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Brand NameARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS
Type of DeviceARCTIC GEL PADS
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 Key10454650
MDR Text Key205688195
Report Number1018233-2020-05465
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Catalogue Number318-02
Device Lot NumberNGEP0417
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 Received12/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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