• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 5000 ARCTIC SUN DEVICE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000E
Device Problems Defective Component (2292); Output below Specifications (3004)
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 arctic sun device was getting low flow , so the nurse filled the reservoir without emptying the pads. The flow rate was 0. 1l/min. Per troubleshooting with ms&s, the nurse was advised that filling the reservoir was not proper troubleshooting for flow. The nurse emptied some water from the drain port to prevent a overfill scenario, but a piece came out of the drain port and the water would not stop draining. Ms&s recommended sending the unit to biomed for evaluation. Biomed evaluated the unit and stated the water level was showing no bars lit up, and the reservoir level was zero. Per troubleshooting with ms&s, a gallon of sterile water was obtained, and the biomed was guided through attempting to fill the reservoir via the fill tube. He stated that the device was not pulling in the water. The fluid delivery line was removed and with a thumb placed over the left port, the biomed reported very little suction. The fluid delivery line was replaced, and he tried again to fill the device but was unsuccessful. Per additional information received via voice message on 17 dec 2019 from biomed, the device flow issue and filling issue was caused by the circulation pump.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARCTICSUN 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 Key9554776
MDR Text Key178786217
Report Number1018233-2020-00127
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741127755
UDI-Public(01)00801741127755
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 02/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2020
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 Received02/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-