INTELEPACS INTELEPACS 4-9-1 AND UP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-25 for INTELEPACS INTELEPACS 4-9-1 AND UP manufactured by Intelerad Medical Systems.

MAUDE Entry Details

Report Number9615916-2020-00002
MDR Report Key9751805
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-02-25
Date of Report2020-02-20
Date of Event2020-02-07
Date Mfgr Received2020-02-07
Device Manufacturer Date2016-11-03
Date Added to Maude2020-02-25
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 ContactMRS LUCE CARON
Manufacturer Street800, BOUL. DE MAISONNEUVE E. 12TH FLOOR
Manufacturer CityMONTREAL, QUEBEC H2L 4L8
Manufacturer CountryCA
Manufacturer PostalH2L 4L8
Manufacturer G1INTELERAD MEDICAL SYSTEMS
Manufacturer Street800, BOUL. DE MAISONNEUVE E. 12TH FLOOR
Manufacturer CityMONTREAL, QUEBEC H2L 4L8
Manufacturer CountryCA
Manufacturer Postal CodeH2L 4L8
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTELEPACS
Generic NamePICTURE ARCHIVING AND COMMUNICATION SYSTEM
Product CodeLLZ
Date Received2020-02-25
Model NumberINTELEPACS 4-9-1 AND UP
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTELERAD MEDICAL SYSTEMS
Manufacturer Address800, BOUL. DE MAISONNEUVE E. 12TH FLOOR MONTREAL, QUEBEC H2L 4L8 CA H2L 4L8


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-25

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