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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 Break (1069); Insufficient Cooling (1130); No Display/Image (1183); Display or Visual Feedback Problem (1184); Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 the arctic sun device displayed an alert 113 ( reduced water temperature control) when the patient was cooling under hypothermia phase. The patient temperature was 33. 6c and the water temperature was 30. 3c. The flow rate was 2. 8lpm. In manual control, the outlet monitor temperature and the outlet control temperature were remained at 30. 3c and the chiller temperature was 3. 9c. Mss advised the nurse to change out the device since it could not deliver cold water. The nurse changed devices and the second device would not display the patient's temperature and displayed an alert 14 ( patient temperature 1 probe out of range). The nurse replaced the cable with the cable from the first device. The patient's temperature then displayed. The therapy was restarted then the flow rate was stabilized at 3. 1 l/min. The cable was labelled as broken and also the arctic sun device was labelled with alert 113 not cooling and sent to the biomed department. Per follow up on (b)(6) 2020, nurse stated the device was sent to biomed and the patient was able to complete therapy on the second device. Unknown about the cable status.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key10151339
MDR Text Key195397026
Report Number1018233-2020-03790
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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