PAGEWRITER TC30 CARDIOGRAPH 860306

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-05 for PAGEWRITER TC30 CARDIOGRAPH 860306 manufactured by Philips Medical Systems.

MAUDE Entry Details

Report Number1218950-2019-05782
MDR Report Key8862127
Date Received2019-08-05
Date of Report2019-07-10
Date Mfgr Received2019-07-10
Date Added to Maude2019-08-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ROBERT CORNING
Manufacturer Street3000 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9786871501
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePAGEWRITER TC30 CARDIOGRAPH
Generic NamePAGEWRITER TC30 CARDIOGRAPH
Product CodeDPS
Date Received2019-08-05
Model Number860306
Catalog Number860306
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-05

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