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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTICSUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Display or Visual Feedback Problem (1184); Filling Problem (1233)
Patient Problem 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 information provided by bd represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that the arcticsun device displayed an alert 113 (reduced water temperature control). The patient temperature was 34. 8c, the target temperature was 35c, the water temperature was 26. 7c, and the flow stopped. The inlet pressure was -10. 3psi and the circulation pump command was running at 0%. Per troubleshooting, the pads were disconnected and reconnected and therapy restarted. The flow rate remained at 0 l/min and the inlet pressure was -11. 8psi. The device was powered off and back on. The device alarmed alarm 05, water reservoir empty. The nurse attempted to fill reservoir, but device did not take the water. It was recommend that the device be sent to biomed.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTICSUN 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 Key8448502
MDR Text Key139809262
Report Number1018233-2019-01504
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeCA
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 04/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2019
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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