BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 276091 · Received April 27, 2000

    Report

    Report Number
    2916596-2000-00018
    Event Type
    Malfunction
    Date Received
    April 27, 2000
    Date of Event
    January 3, 2000
    Report Date
    January 3, 2000
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A PT WITH LEFT AND RIGHT VENTRICULAR ASSIST DEVICES WAS BEING PREPARED TO BE MOVED TO ICU FROM THE OPERATING ROOM AFTER VENTRICULAR ASSIST DEVICE IMPLANT. UPON DISCONNECTING THE DUAL DRIVE CONSOLE FROM AC POWER, BOTH COMPRESSORS FAILED. UPON RECONNECTING THE DDC BACK TO AC POWER SUPPLY, THE COMPRESSORS RESUMED WORKING. THE PT WAS SWITCHED TO A BACK UP DRIVER. THERE WAS NO REPORTED EFFECT ON THE PT. THE DEVICE WAS EVAL AT THE SITE AND THE BATTERY PACK FOR UNINTERRUPTIBLE POWER SUPPLY WAS REPLACED. THE FAULTY BATTERY PACK WAS SENT TO THORATEC FOR FURTHER INVESTIGATION. THE UPS BATTERY PACK CONTAINING SIX INDIVIDUAL 12VDC BATTERIES WAS INSPECTED AND EVALUATED. THE CAUSE OF FAILURE WAS IDENTIFIED EXCESSIVE INTERNAL RESISTANCE IN ONE OF THE SIX BATTERIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *