BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPSYSTEM 2A

    MDR report key: 459812 · Received May 9, 2003

    Report

    Report Number
    1927197-2003-00007
    Event Type
    Malfunction
    Date Received
    May 9, 2003
    Date of Event
    September 5, 1997
    Report Date
    May 1, 2003
    Manufacturer
    SEECOR, INC.
    Product Code
    DTE
    Removal / Correction Number
    Z-981-6
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNIT SERIAL # IS AN OLDER PROTYPE WITH NO SHIELDING, NEEDS TO BE REFURBISHED WITH IMPROVED EMI RESISTANCE. UNIT WAS NOT IN USE ON A PT. LATER THE HOSP DECIDED NOT TO RETURN THE UNIT FOR REFURBISHING. ANOTHER TWO DEVICES WERE INCLUDED ON THE RGA TO CARDIOCOMMAND, INC., WERE NOT A PROBLEM WITH EMI, BUT THOUGHT TO HAVE A PROBLEM WITH POWERING UP. LATER THE HOSP FOUND THEIR MISTAKE WITH POWERING UP THE UNITS AND DECIDED NOT TO RETURN FOR REPAIR SINCE THE UNITS WERE OPERATIONAL. THESE 2 UNITS HAD ALREADY BEEN MODIFIED FOR IMPROVED EMI RESISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPSYSTEM 2A ESOPHAGEAL PACING SYSTEM DTE SEECOR, INC. 2A *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other