• 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 Device Displays Incorrect Message (2591); Device Sensing Problem (2917); Unexpected Shutdown (4019)
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 there was a device sensing issue in the arctic sun device. Biomed had the device in his shop. The nurses reported that it shut off on its own during therapy. Ms&s had him check the event log. Alarm 14 was in the log, and ms&s explained the alarm. He stated he would get a temperature simulation key and test the cable. Ms&s explained that would stop therapy, but not power the device off. If the device was powered off, ensure it was connected to a wall outlet and not a bed. Ms&s differed to look at a data download, but the biomed declined. Per follow up, the biomed stated he talked with tech support, and they where going to send the device in and get a loaner.
 
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 Key9607297
MDR Text Key180397849
Report Number1018233-2020-00435
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2020
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 Received02/27/2020
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

-
-