INTELLISPHERE EVENT MANAGEMENT 866030

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 2019-09-26 for INTELLISPHERE EVENT MANAGEMENT 866030 manufactured by Philips Medical Systems.

MAUDE Entry Details

Report Number1218950-2019-07383
MDR Report Key9125090
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-09-26
Date of Report2019-09-13
Date of Event2019-09-10
Date Mfgr Received2019-09-13
Device Manufacturer Date2016-11-21
Date Added to Maude2019-09-26
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 ContactMS. BETTY HARRIS
Manufacturer Street3000 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9786871501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTELLISPHERE EVENT MANAGEMENT
Generic NameCOMMUNICATION SYSTEM
Product CodeMSX
Date Received2019-09-26
Model Number866030
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2019-09-26

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