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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 2000 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 2000 ARCTIC SUN DEVICE Back to Search Results
Catalog Number 2000-02
Device Problems Break (1069); Fluid Leak (1250); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems No Patient Involvement (2645); 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 during the evaluation that the arctic sun device failed acats due to a faulty processor card. The device was an obsolete product and the unit could not be repaired. The isolation card had a damaged pt out port. The fdl was leaking from both valve bodies and from the ¿y¿ connector.
 
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Brand NameARCTICSUN 2000
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 Key9220393
MDR Text Key168806923
Report Number1018233-2019-06646
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2000-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2008
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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