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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 Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182); Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)
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 user was getting a low flow alert but flow was currently at 1. 2 l/m but would fluctuate down to 0. 8 l/m. The neonate was at 33. 2c and the target temperature was 33. 5c. Ms&s disconnected and reconnected the arctic gel pads using proper technique with no improvement in flow. The user had tried flipping connection of +/- and ran diagnostics, then the flow was in 2 l/m range, the inlet pressure was in-9 psi range and the circulation pump command was in 60% range. The user reconnected and flow was back down to 0. 8 l/m. At the end of troubleshooting, the temperature began to fluctuate and became erratic reading 28-32c. Ms&s advised to get another arctic gel device and if still getting low flow and change out the arctic gel pad.
 
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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 Key10474214
MDR Text Key206106576
Report Number1018233-2020-05589
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2020
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 Received01/21/2021
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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