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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 Device Alarm System (1012); Device Sensing Problem (2917); Pressure Problem (3012)
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.
 
Event Description
It was reported that the arcticsun device (sn (b)(4)) displayed an alarm 14 (patient temperature 1 probe out of range), an alert 51 (patient temperature 1 below control range) and an alert 114 (treatment stopped). The flow rate was 0l/min, the inlet pressure was -0. 7psi, and the circulation pump command was 100%. Per troubleshooting, the device was placed in manual control with only the fluid delivery line attached. The flow rate was 1. 8l/min, the inlet pressure was -7. 1psi, and the circulation pump command was 32%. The pads were reconnected and the flow rate increased to 3. 4l/min. The nurse was called back and stated the flow rate decreased again. It was then reported that the issue persisted so the device was switched (sn (b)(4)). The nurse stated the new device was not heating the patient. The target was 36c, the patient was 32. 7c, the water was 32. 7c, and the flow rate was 0. 4l/min. Per troubleshooting, the pads were disconnected and reconnected using the proper technique. The nurse called back and stated the issue persisted. The flow rate was 0. 9l/min, the inlet pressure was -6. 8psi, an the circulation pump command was 37%. The device was placed in manual control. The flow rate was 1. 1l/min the inlet pressure was -6. 9psi, the circulation pump command was 37% and the cv was 1. The device was switched back to (sn (b)(4)). The system hours were 2564 and pump hours were 14049; with only the fluid delivery line attached, the flow rate was 0l/min, the inlet pressure was -9. 1psi, the circulation pump was 0% and the cv was 0. The nurse was advised to locate a 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
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 Key10106796
MDR Text Key193931649
Report Number1018233-2020-03508
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2020
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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

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