BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE

    MDR report key: 521873 · Received April 19, 2004

    Report

    Report Number
    521873
    Event Type
    Other
    Date Received
    April 19, 2004
    Date of Event
    August 1, 2003
    Report Date
    April 1, 2004
    Manufacturer
    THORATEC LAB, CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A THORATEC VENTRICULAR ASSIST DEVICE WAS NOT SENDING A "FILL SIGNAL" AND THIS PRODUCED AN ALARM. THE DEVICE FUNCTION APPEARED NORMAL, AND [THERE WAS] NO CHANGE IN THE PT'S CONDITION. ALL ATTEMPTS TO RESOLVE WERE UNSUCCESSFUL. THORATEC'S EMERGENCY LINE WAS CALLED, BUT COULD NOT RESOLVE OVER THE PHONE. THORATEC [IS GOING TO] INVESTIGATE AND MAKE ADJUSTMENTS ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE VENTRICULAR ASSIST DEVICE DSQ THORATEC LAB, CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other