ARCTIC SUN 5000 50000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-18 for ARCTIC SUN 5000 50000000 manufactured by Medivance, Inc. ? 1725056.

Event Text Entries

[186175282] The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[186175283] It was found during evaluation that the right drain valve was leaking, the right angle power cord insulation was pulling loose from the restraining grommet exposing the inner wires, and there were 4 valves leaking on the fluid delivery line that will need new o rings.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-01899
MDR Report Key9850114
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2020-03-18
Date of Report2020-04-03
Date Mfgr Received2020-03-30
Device Manufacturer Date2015-06-01
Date Added to Maude2020-03-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactYONIC ANDERSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1MEDIVANCE, INC.
Manufacturer Street321 S TAYLOR AVE
Manufacturer CityLOUISVILLE CO 80027
Manufacturer CountryUS
Manufacturer Postal Code80027
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARCTIC SUN 5000
Generic NameARCTIC SUN DEVICE
Product CodeDWJ
Date Received2020-03-18
Returned To Mfg2020-02-13
Model Number50000000
Catalog Number50000000
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDIVANCE, INC. ? 1725056
Manufacturer Address321 S TAYLOR AVE LOUISVILLE CO 80027 US 80027


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

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