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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
Catalog Number 5000-01-01
Device Problems Filling Problem (1233); Restricted Flow rate (1248); Unexpected Therapeutic Results (1631)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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's inlet pressure ranged between -5psi and 5psi. It was also noted that the circulation pump was operating at 100%. The device could not be filled, and was replaced prior to use. Additional information was received from the complainant on 4jun2019 that there was no issue with the set of gel pads. The issue was found at the start of therapy. The patient was switched to a second device to complete therapy.
 
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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 Key8771247
MDR Text Key150573789
Report Number1018233-2019-03722
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeGM
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 08/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5000-01-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
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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