BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

    MDR report key: 104149 · Received July 11, 1997

    Report

    Report Number
    1220648-1997-00024
    Event Type
    Malfunction
    Date Received
    July 11, 1997
    Date of Event
    June 13, 1997
    Report Date
    July 8, 1997
    Manufacturer
    ABIOMED, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE CHECK OF THE BVS CONSOLE, THE CHARGING LIGHT DID NOT ILLUMINATE. IT WAS FOUND THAT THE MOV HAD SHORTED. IT WAS REMOVED AND THE FUSES REPLACED. THERE HAVE BEEN NO FURTHER PROBLEMS. A PT WAS NOT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM Implant CARDIAC ASSIST DEVICE DSQ ABIOMED, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *