PACSCUBE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-25 for PACSCUBE manufactured by Datcard Systems, Inc.

Event Text Entries

[44364952] Customer plugged monitor and pc into the power supply, then plugged power supply into power outlet. When he pushed the power button on the power supply, it sparked and began to flame.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003341080-2016-00001
MDR Report Key5605403
Date Received2016-04-25
Date of Event2016-04-21
Date Mfgr Received2016-04-21
Date Added to Maude2016-04-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer Street7 GOODYEAR
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9499321300
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePACSCUBE
Generic NameDIGITAL IMAGE COMMUNICATIONS DEVICE
Product CodeLMD
Date Received2016-04-25
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDATCARD SYSTEMS, INC
Manufacturer Address7 GOODYEAR IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2016-04-25

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