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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 50000000E
Device Problems Insufficient Cooling (1130); Failure to Pump (1502)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that hypothermia patient was cooling on the arctic sun device with a 36c target. Nurse reported the device was sounding alert 113 (reduced water temperature control) intermittently. Patient temperature was 36. 2c, water temperature was 28. 9c and flow rate was 3lpm. System diagnostics showed that mixing pump command was 100 percent and chiller temperature (t4) was 6c. Nurse stated that the device made warm water to 39c when the patient got too cool, but the water temperature had not dropped when the patient temperature rose above the target temperature. Mss recommended the nurse to change to a different device and send the first one to biomedical engineering department for repair. Mss asked the nurse to label device not circulating cold water and explained how to empty arctic gel pads into this device and how to connect pads to the new device.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that hypothermia patient was cooling on the arctic sun device with a 36c target. Nurse reported the device was sounding alert 113 (reduced water temperature control) intermittently. Patient temperature was 36. 2c, water temperature was 28. 9c and flow rate was 3lpm. System diagnostics showed that mixing pump command was 100 percent and chiller temperature (t4) was 6c. Nurse stated that the device made warm water to 39c when the patient got too cool, but the water temperature had not dropped when the patient temperature rose above the target temperature. Mss recommended the nurse to change to a different device and send the first one to biomedical engineering department for repair. Mss asked the nurse to label device not circulating cold water and explained how to empty arctic gel pads into this device and how to connect pads to the new device.
 
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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
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13591970
MDR Text Key286081791
Report Number1018233-2022-00851
Device Sequence Number1
Product Code DWJ
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 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2017
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: 02/24/2022 Patient Sequence Number: 1
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