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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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS Back to Search Results
Catalog Number 318-02
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/25/2021
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 a (b)(6) old baby who weighed about (b)(6) kg was in arctic sun device which received a low flow alert. The nurse was trying to fill and stated that the flow was around 1. 2 lpm until recently. The nurse noticed a kink and corrected it and stated the water level was full and no water was needed. The nurse stated the patient arrived cold at 33. 1c and were doing a controlled rewarm to 36 c the water temperature was 27. 9 c the patient was on neonatal pad the flow was between 0. 8 lpm and 1. 2lpm the inlet pressure was -7. 0 psi circulation pump was 23 percent and heater command was 12 percent. The nurse stated that they did not stock small universal pads the length of the pad fitted the baby but the sides did not fully cover the abdomen. Ms and s suggested to continue monitoring the flow the water temperature and heater command. Ms and s explained that when the flow drops was too low then the heater would not be able to function properly.
 
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Brand NameARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
Type of DeviceARCTICGEL¿ 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 Key12639720
MDR Text Key276645164
Report Number1018233-2021-06433
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 Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number318-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/15/2021 Patient Sequence Number: 1
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