ARCTIC SUN 5000 50000000E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2019-12-19 for ARCTIC SUN 5000 50000000E manufactured by Medivance, Inc. ? 1725056.

Event Text Entries

[178963974] 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


[178963975] It was reported that the arctic sun device was not cooling.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2019-08101
MDR Report Key9497241
Report SourceHEALTH PROFESSIONAL,OTHER,USE
Date Received2019-12-19
Date of Report2020-02-21
Date Mfgr Received2020-02-20
Device Manufacturer Date2016-02-01
Date Added to Maude2019-12-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
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 CodeDWF
Date Received2019-12-19
Returned To Mfg2019-12-18
Model Number50000000E
Catalog Number50000000E
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 2019-12-19

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