BEUDAMED
    FDA Adverse Event Other Summary report: N

    TLC-II PORTABLE VAD SYSTEM-POWER SUPPLY

    MDR report key: 514928 · Received March 9, 2004

    Report

    Report Number
    2916596-2004-00035
    Event Type
    Other
    Date Received
    March 9, 2004
    Date of Event
    February 10, 2004
    Report Date
    February 12, 2004
    Manufacturer
    THORATEC 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

    IN 2004 IT WAS REPORTED BY THE BIOMEDICAL DEPARTMENT TAHT THE EXTERNAL POWER SUPPLY/POWER ADAPTER (A COMPONENT OF THE VENTRICULAR ASSIT DEVICE (VAD) SYSTEM) WAS RUNNING HOT AND CAUSED A MINOR BURN TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TLC-II PORTABLE VAD SYSTEM-POWER SUPPLY POWER ADAPTER DSQ THORATEC CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other