BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 272520 · Received April 3, 2000

    Report

    Report Number
    2916596-2000-00006
    Event Type
    Malfunction
    Date Received
    April 3, 2000
    Date of Event
    March 9, 2000
    Report Date
    March 9, 2000
    Manufacturer
    THORATEC LABORATORIES, CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS A PT WAS BEING PREPARED TO BE TRANSPORTED FROM THE O.R. TO THE ICU, WHEN THE DUAL DRIVE CONSOLE (DDC) WAS UNPLUGGED FROM AC POWER, THE TOP MODULE SHUT DOWN. THE DDC WAS IMMEDIATELY RECONNECTED TO AC POWER, AND THE MODULE RESUMED OPERATION. ANOTHER ATTEMPT WAS MADE TO DISCONNECT THE DDC FROM AC POWER, BUT THE MODULE CEASED TO FUNCTION AGAIN. THE PT WAS SWITCHED TO A BACK-UP DRIVER. THERE WAS NO REPORTED EFFECT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM VENTRICULAR ASSIST DEVICE, DUAL DRIVE CONSOLE DSQ THORATEC LABORATORIES, CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR