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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); No Display/Image (1183)
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. The device was not returned.
 
Event Description
It was reported that a normothermia patient was on the device with a 37c target temperature but there was no graph on the screen. The complainant said there was only a screen that showed controlling patient at 37c. She was told that the device had not been programmed yet. Per troubleshooting, ms&s stated that the graph area was blank after receiving a screen shot. The manual control box was in the upper right corner of the screen. The complainant rebooted the device. There was a hypothermia and normothermia choice on the patient therapy selection screen, however, when she chose normothemia, the device went to the screen saver screen. The screen saver screen showed the water temperature and patient temperature. There was no change after rebooting the device. The complainant was advised to switch the patient to a second device and send this device to the biomed. Ms&s called back approximately one hour later and confirmed the patient was continuing therapy successfully on the second device. Per additional information from biomed (b)(6) on (b)(6) 2018, the sales rep reinstalled the software and the device functioned normally. The device has been sent back into 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 Key7895322
MDR Text Key121442229
Report Number1018233-2018-04331
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 11/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2018
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 Received10/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2012
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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