PAGEWRITER TOUCH CARDIOGRAPH 860315

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-01 for PAGEWRITER TOUCH CARDIOGRAPH 860315 manufactured by Philips Medical Systems.

Event Text Entries

[140606573] A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[140606574] The customer reported that the unit was freezing up and the screen went black while the device was connected to a patient in the emergency department and they lost the study.
Patient Sequence No: 1, Text Type: D, B5


[147901901] .
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1218950-2019-02486
MDR Report Key8471081
Date Received2019-04-01
Date of Report2019-03-20
Date Mfgr Received2019-03-20
Device Manufacturer Date2014-09-03
Date Added to Maude2019-04-01
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 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 TOUCH CARDIOGRAPH
Generic NamePAGEWRITER TC70 CARDIOGRAPH
Product CodeDPS
Date Received2019-04-01
Model Number860315
Catalog Number860315
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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
10 2019-04-01

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