IMPELLA RP IMPELLA RP US PUMP SET 004334

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 2019-07-01 for IMPELLA RP IMPELLA RP US PUMP SET 004334 manufactured by Abiomed, Inc..

MAUDE Entry Details

Report Number1220648-2019-00128
MDR Report Key8748901
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-07-01
Date of Report2019-09-03
Date of Event2019-06-07
Date Facility Aware2019-06-07
Date Mfgr Received2019-08-12
Device Manufacturer Date2019-01-17
Date Added to Maude2019-07-01
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. RALPH BARISANO
Manufacturer Street22 CHERRY HILL DR.
Manufacturer CityDANVERS MA 01923
Manufacturer CountryUS
Manufacturer Postal01923
Manufacturer G1ABIOMED, INC.
Manufacturer Street22 CHERRY HILL DR.
Manufacturer CityDANVERS MA 01923
Manufacturer CountryUS
Manufacturer Postal Code01923
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMPELLA RP
Generic NameTEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP
Product CodePYX
Date Received2019-07-01
Returned To Mfg2019-06-18
Model NumberIMPELLA RP US PUMP SET
Catalog Number004334
Lot Number1386766
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABIOMED, INC.
Manufacturer Address22 CHERRY HILL DR. DANVERS MA 01923 US 01923


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-01

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