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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-PAD

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS ARCTIC GEL-PAD Back to Search Results
Catalog Number 317-07
Device Problems Display or Visual Feedback Problem (1184); Inaccurate Flow Rate (1249); Gas Leak (2946); Infusion or Flow Problem (2964)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 09/02/2020
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 low flow and air leak detected and alerted on the device. It was also stated that the device was changed to another device but still low flow and air leak alerted. Pads were changed and therapy was resumed, the flow increased to above 2. 2 l/min and no air leak was detected. As air leak was alerted on the device, the alarm continued , flow was low (1. 2l/min) and targeted temperature was not reached.
 
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Brand NameARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS
Type of DeviceARCTIC GEL-PAD
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 Key10575270
MDR Text Key208749059
Report Number1018233-2020-06173
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Catalogue Number317-07
Device Lot NumberNGEP2681
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2020
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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