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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 2000 ARCITCSUN DEVICE Back to Search Results
Catalog Number 2000-03
Device Problems Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895)
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 that the device did not pass the hygienic sampling, due to having a high germ load. There was no patient involvement.
 
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Brand NameARCTIC SUN 2000
Type of DeviceARCITCSUN 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 Key8364135
MDR Text Key137374675
Report Number1018233-2019-01000
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K071341
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 04/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2000-03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2007
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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