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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 50000000E
Device Problems Display or Visual Feedback Problem (1184); Component Missing (2306); Device Dislodged or Dislocated (2923)
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 evaluated by a biomedical technician at the complainant's facility.
 
Event Description
It was reported that the arctic sun device displayed a non-recoverable error message. The device was restarted and the issue was not resolved. Per follow up, the patient was switched to an alternate device and the patient reached the target temperature and completed therapy. Per additional information received on 19apr2019, biomed ed stated that he repaired the device and placed it back into service. He stated there was a screw missing under the screen that held the circuit board in place. The missing screw allegedly allowed the board to vibrate out of place. He confirmed that there have been no further issues with the device.
 
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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 Key8541905
MDR Text Key143986291
Report Number1018233-2019-02128
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 05/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2019
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 Received05/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2017
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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