OMNICELL I.V.STATION I.V. STATION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-04 for OMNICELL I.V.STATION I.V. STATION manufactured by Aesynt Incorporated.

MAUDE Entry Details

Report Number3011278888-2020-00008
MDR Report Key9787295
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-04
Date of Report2020-03-04
Date of Event2020-02-11
Date Mfgr Received2020-02-13
Device Manufacturer Date2018-02-27
Date Added to Maude2020-03-04
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. DAVID VANELLA
Manufacturer Street500 CRANBERRY WOODS DRIVE SUITE 400
Manufacturer CityCRANBERRY TOWNSHIP, PA
Manufacturer CountryUS
Manufacturer Phone7418115
Manufacturer G1AESYNT INCORPORATED
Manufacturer Street51 PENNWOOD PLACE
Manufacturer CityWARRENDALE, PA
Manufacturer CountryUS
Single Use3
Remedial ActionMA
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOMNICELL I.V.STATION
Generic NamePHARMACY COMPOUNDING DEVICE
Product CodeNEP
Date Received2020-03-04
Model NumberI.V. STATION
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAESYNT INCORPORATED
Manufacturer Address51 PENNWOOD PLACE WARRENDALE, PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-04

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