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Adverse Event Report

ABIOMED, INC. BVS 5000I BI-VENTRICULAR SUPPORT SYSTEM CARDIAC ASSIST DEVICE   back to search results
Catalog Number 0005-0010
Event Date 06/09/2000
Event Type  Malfunction  
Event Description

During bi-ventricular assist device support, the bvs console would not go into right side weaning. Abiomed field service has replaced the weaning board and there have been no further problems. There was no impact to the pt.

 
Manufacturer Narrative

This console is part of the ongoing recalls z-351-0 and z-352-0, which require replacement of the weaning board in the field. This unit had not been serviced yet. Abiomed field service has now replaced the weaning board and there have been no further problems.

 
Search Alerts/Recalls

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Brand NameBVS 5000I BI-VENTRICULAR SUPPORT SYSTEM
Type of DeviceCARDIAC ASSIST DEVICE
Baseline Brand NameBVS 5000 CONSOLE
Baseline Generic NameCARDIAC ASSIST DEVICE
Baseline Catalogue Number0005-0010
Baseline Device FamilyNA
Baseline Device 510(K) Number
Baseline Device PMA NumberP900023
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed12/22/1992
Manufacturer (Section F)
ABIOMED, INC.
33 cherry hill dr
danvers MA 01923
Manufacturer (Section D)
ABIOMED, INC.
33 cherry hill dr
danvers MA 01923
Manufacturer (Section G)
ABIOMED, INC.
33 cherry hill drive
danvers MA 01923
Manufacturer Contact
janice piasecki
33 cherry hill drive
danvers , MA 01923
(978) 646 -1477
Device Event Key274400
MDR Report Key283559
Event Key265985
Report Number1220648-2000-00014
Device Sequence Number1
Product CodeDSQ
Report Source Manufacturer
Source Type User facility,Health Professional
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial
Report Date 06/21/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0005-0010
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/09/2000
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/1999
Is The Device Single Use? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on February 28, 2009

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