PHILIPS XPER FLEX CARDIO PHYSIOMONITORIG SYSTEM FC2010 453564634201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-24 for PHILIPS XPER FLEX CARDIO PHYSIOMONITORIG SYSTEM FC2010 453564634201 manufactured by Invivo Corporation.

Event Text Entries

[187939310] A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[187939311] The customer reported that the nibp (non-invasive blood pressure) would take the first set of vitals then each 5 min. Vital after would appear to pump up but would give the same values. 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 Number1051786-2020-00006
MDR Report Key9744110
Report SourceUSER FACILITY
Date Received2020-02-24
Date of Report2020-02-12
Date Mfgr Received2020-02-12
Device Manufacturer Date2017-06-20
Date Added to Maude2020-02-24
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 Report3

Device Details

Brand NamePHILIPS XPER FLEX CARDIO PHYSIOMONITORIG SYSTEM
Generic NamePHYSIOMONITORYING SYSTEM, INFO
Product CodeMWI
Date Received2020-02-24
Model NumberFC2010
Catalog Number453564634201
Lot NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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 2020-02-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.