HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK 2050US

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 2020-03-31 for HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK 2050US manufactured by Heartware, Inc..

MAUDE Entry Details

Report Number3007042319-2020-02774
MDR Report Key9908281
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-27
Date Mfgr Received2020-03-30
Device Manufacturer Date2020-01-13
Date Added to Maude2020-03-31
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 ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1HEARTWARE, INC.
Manufacturer Street14400 NW 60TH AVE
Manufacturer CityMIAMI LAKES FL 33014
Manufacturer CountryUS
Manufacturer Postal Code33014
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK
Generic NameVENTRICULAR (ASSIST) BYPASS
Product CodeDSQ
Date Received2020-03-31
Model Number2050US
Catalog Number2050US
Lot Number1607352
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHEARTWARE, INC.
Manufacturer Address14400 NW 60TH AVE MIAMI LAKES FL 33014 US 33014


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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