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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 Problem Insufficient Cooling (1130)
Patient Problems Convulsion/Seizure (4406); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2021
Event Type  malfunction  
Event Description
It was reported that the patient was cooling to a target temperature of 33c on the arctic sun device. Therapy began around 1 pm and the device was getting an alert 113 (reduced water temperature control). Patient temperature was 35. 8c, flow rate was 2. 8lpm, water temperature was 7. 2c, chiller temperature (t4) was 3. 7c, mixing pump command was 100 percent, pump hours were 2130 and system hours were 2379. Mss suggested closing out the alert and monitoring the patient and water temperatures. The device was attempting to make water temperature at 4c, but the water temperature was only 7c. The patient was not shivering but might be seizing. There were some twitching motions and patient was biting down on their tube. Mss advised to address heat generation per facility protocol. They had a bair hugger on and recently decreased the temperature on it. 2 hours later, patient temperature was down to 33. 9c, the water temperature was increasing, and they were no longer getting alert 113 (reduced water temperature control).
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
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 the patient was cooling to a target temperature of 33c on the arctic sun device. Therapy began around 1 pm and the device was getting an alert 113 (reduced water temperature control). Patient temperature was 35. 8c, flow rate was 2. 8lpm, water temperature was 7. 2c, chiller temperature (t4) was 3. 7c, mixing pump command was 100 percent, pump hours were 2130 and system hours were 2379. Mss suggested closing out the alert and monitoring the patient and water temperatures. The device was attempting to make water temperature at 4c, but the water temperature was only 7c. The patient was not shivering but might be seizing. There were some twitching motions and patient was biting down on their tube. Mss advised to address heat generation per facility protocol. They had a bair hugger on and recently decreased the temperature on it. 2 hours later, patient temperature was down to 33. 9c, the water temperature was increasing, and they were no longer getting alert 113 (reduced water temperature control).
 
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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 Key13094381
MDR Text Key285408668
Report Number1018233-2021-08464
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 01/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
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 Received01/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/28/2021 Patient Sequence Number: 1
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