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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 Computer Software Problem (1112); Defective Component (2292); Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)
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 bard 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 bard.
 
Event Description
It was reported that the device was giving an alert 113. The patient temperature was in 34c range, target temperature was 33c, water temperature was 28. 1c, and there were three bars on the water level. Per follow up with nurse (b)(6) via phone on (b)(6) 2018, therapy was discontinued and the device was sent to biomed. She stated that they did not have another device, so the patient was cooled using a cooling blanket. Per biomed (b)(6) via phone on (b)(6) 2018, he could not find anything wrong with the device and it would be returned to service once the service technician updated the software and the device passed testing. Per additional information received on (b)(6) 2018 via biomed (b)(6) troubleshooting with ms&s, manual control was set to 42c and the water heated up. When the manual control was set to 4c, the water temperature did not drop. The water temperature was noted at 32. 5c. The t4 chiller temperature was 3. 9c, and t1 and t2 remained at 32. 5c. The pump hours were noted at 1303 and the system hours were noted at 1448. Additional information was received via phone with biomed (b)(6) on (b)(6) 2018. He stated that, per troubleshooting with technical support, it was determined that the issue was isolated to the mixing pump. He stated that he ordered the new mixing pump and would be making the repairs himself onsite. After the repairs, the device would be returned to service.
 
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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 Key7927933
MDR Text Key122657993
Report Number1018233-2018-04551
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 health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2018
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 Received10/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2014
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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