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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN DEVICE Back to Search Results
Model Number 60000000
Device Problems Overfill (2404); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2022
Event Type  malfunction  
Event Description
It was reported that neonate was cooling on the arctic sun device for the last hour. Nurse reported that this was only the second time the device was used, and it sounded alarm 113 (reduced water temperature control). Mss explained what alarm 113 (reduced water temperature control) meant. They were currently getting x-rays and placing intravenous lines. Nurse asked mss to call back in 15 minutes as they were unable to troubleshoot now. 15 minutes later, water reservoir level was 5 bars. Nurse drained 500ml of water from the right drain port. Patient temperature was 32c, target temperature was 33. 5c, water temperature was 39. 8c and flow rate was 0. 7lpm. Water control showed that inlet pressure was -7 psi and circulation pump command was 28 percent. Mss had the nurse look for bends or kinks in the pad tubing and fluid delivery line (fdl) and nurse saw no bends or kinks in the pad tubing. The fluid delivery line (fdl) was wrapped around the device. Nurse straightened out the fluid delivery line (fdl) tubing and the flow rate rose to 1lpm. Mss recommended the nurse to find a way to support the fluid delivery line (fdl) so it does not bend and the flow rate stays up.
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
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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
juan velez
8195 industrial blvd
covington 30014
MDR Report Key13861012
MDR Text Key287681445
Report Number1018233-2022-01488
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741161513
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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 07/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60000000
Device Catalogue Number60000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/23/2022 Patient Sequence Number: 1