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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Insufficient Cooling (1130); Failure to Pump (1502)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2022
Event Type  malfunction  
Event Description
It was reported that normothermia patient was on the arctic sun device and nurse stated the device was alarming but did not believe the device was functioning properly. Patient temperature was 37. 6c, target temperature was 37c, water temperature was 32c and flow rate was 2. 4lpm. Event log showed multiple alert 113 (reduced water temperature control) and alert 116 (patient temperature 1 change not detected). Chiller temperature (t4) was 4. 3c and mixing pump command was 100 percent. Mss explained what alert 113 meant and advised that the device was unable to make water to the desired temperature. Mss also recommended the nurse to change the device and told them to empty the pads into this device and send to the clinical engineering department for repair labeled alert 113 (reduced water temperature control). Per additional information received on 07-mar-22, biomed stated they would order and replace the mixing pump onsite. Per follow up information received on 08-mar-2022, biomed would order a mixing pump and fix it onsite, the device was being used on a patient during the reported event with no reported injury. It was unknown if the patient completed therapy on same device. Per follow up information received on 11-mar-2022, the mixing pump was one of the components that made cold water for therapy, so as a result of the pump failure it caused an inability to cool. There were no other failures reported.
 
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® 5000
Type of DeviceARCTIC SUN DEVICE
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
7707846100
MDR Report Key13930024
MDR Text Key288051213
Report Number1018233-2022-01665
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
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 08/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2014
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: 03/28/2022 Patient Sequence Number: 1
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