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 company representative,health report with the FDA on 2019-10-23 for OMNICELL I.V.STATION I.V. STATION manufactured by Aeysnt Incorporated.

MAUDE Entry Details

Report Number3011278888-2019-00094
MDR Report Key9226637
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-10-23
Date of Report2019-10-23
Date of Event2019-10-01
Date Mfgr Received2019-10-01
Device Manufacturer Date2018-07-24
Date Added to Maude2019-10-23
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 16066
Manufacturer CountryUS
Manufacturer Postal16066
Manufacturer Phone7247418115
Manufacturer G1AESYNT INCORPORATED
Manufacturer Street51 PENNWOOD PLACE
Manufacturer CityWARRENDALE PA 15086
Manufacturer CountryUS
Manufacturer Postal Code15086
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 Received2019-10-23
Model NumberI.V. STATION
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAEYSNT INCORPORATED
Manufacturer Address51 PENNWOOD PLACE WARRENDALE PA 15086 US 15086


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-10-23

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