ST8OI STRESS TEST SYSTEM 860343

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 2020-03-13 for ST8OI STRESS TEST SYSTEM 860343 manufactured by Philips Medical Systems.

Event Text Entries

[186135010] Customer reported a patient's name in an exam was overridden with a different name. The device was in use on a patient. There was no report of patient or user harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1218950-2020-01671
MDR Report Key9828983
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-13
Date of Report2020-03-03
Date Mfgr Received2020-03-03
Device Manufacturer Date2015-03-23
Date Added to Maude2020-03-13
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 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 Report3

Device Details

Brand NameST8OI STRESS TEST SYSTEM
Generic NamePHILIPS ST8OI STRESS TEST SYSTEM
Product CodeDQK
Date Received2020-03-13
Model Number860343
Catalog Number860343
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-13

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