Xper Flex Cardio Physiomonitoring System FC2010 453564621791

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for Xper Flex Cardio Physiomonitoring System FC2010 453564621791 manufactured by Invivo Corporation.

MAUDE Entry Details

Report Number1051786-2019-00037
MDR Report Key9145284
Date Received2019-10-02
Date of Report2019-09-19
Date Mfgr Received2019-09-19
Device Manufacturer Date2019-01-03
Date Added to Maude2019-10-02
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 Street12151 RESEARCH PARKWAY SUITE 200
Manufacturer CityORLANDO FL 32826
Manufacturer CountryUS
Manufacturer Postal32826
Manufacturer G1PHILIPS MEDICAL SYSTEMS
Manufacturer Street3000 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal Code01810
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameXper Flex Cardio Physiomonitoring System
Generic NamePHYSIOLOGICAL PATIENT MONITOR
Product CodeMWI
Date Received2019-10-02
Model NumberFC2010
Catalog Number453564621791
Lot NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINVIVO CORPORATION
Manufacturer Address12151 RESEARCH PARKWAY SUITE 200 ORLANDO FL 32826 US 32826


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-02

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