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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 317-07
Device Problems Restricted Flow rate (1248); Inaccurate Flow Rate (1249)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2021
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 the there was no water flow into the pad in the targeted temperature management (ttm) treatment after attaching the arctic gel pad to the patient. It was also reported that the arctic sun 5000 device flow rate was 0 lpm with low flow alarms. The customer emptied the pads several times, reconnected all the four pads and checked for any leakage from the pads. The nurse changed the pads to other arctic sun 5000 machines, but still the flow rate was 0 lpm. Also, reported that the flow rate was maintained at 1. 8 - 1. 9 lpm after changing the gel pads.
 
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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
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key11381689
MDR Text Key233745378
Report Number1018233-2021-00827
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Catalogue Number317-07
Device Lot NumberNGES1146
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/25/2021 Patient Sequence Number: 1
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