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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 NEONATAL ARCTICGEL PAD

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS NEONATAL ARCTICGEL PAD 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 11/23/2021
Event Type  malfunction  
Event Description
It was reported that nurse was gathering information for potential causes for low flow alert 02 in the arctic sun device. The nurse stated that the device was not there and they have noticed it could be when the arctic gel pad was kinked and sometimes when the parent holds the neonate. Mss discussed with nurse about the acceptable flow rate for a neonatal pad and explained kinks in line and connection of pads to fluid delivery line could be a potential reason. Also mss explained if the nurses call the helpline with alert 02 (low flow) mss able to assist with diagnostics to ensure that device was working appropriately. Also nurse stated the target temperature was maintained during alert 02 (low flow) as far as known.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
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Brand NameARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
Type of DeviceNEONATAL ARCTICGEL PAD
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 Key12981430
MDR Text Key283834397
Report Number1018233-2021-07948
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 01/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2021
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 Received01/28/2022
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: 12/10/2021 Patient Sequence Number: 1
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