BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WITT BIOMEDICAL CORP

    MDR report key: 301883 · Received October 25, 2000

    Report

    Report Number
    MW1020246
    Event Type
    Malfunction
    Date Received
    October 25, 2000
    Date of Event
    September 28, 2000
    Report Date
    October 2, 2000
    Manufacturer
    WITT BIOMEDICAL CORP.
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AFTER COMPLETING CARDIAC CATHETERIZATION PROCEDURE, THE NURSE AND TECH RETURNED TO THE ROOM AND NOTICED A BURNING SMELL. THE ROOM THEN BEGAN TO FILL WITH SMOKE WHICH WAS EMANATING FROM THE WITT PT INTERFACE COMPUTER. BIOMEDICAL ENGINEERING STAFF REMOVED THE DEVICE. UPON INVESTIGATION, THEY OBSERVED THAT A COMPONENT ON THE NETWORK BOARD WAS BURNED. A CORD CONNECTOR ON THE MOTHER BOARD WAS MELTED, RESULTING IN THE SMOKE. THE MFR WAS CALLED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WITT BIOMEDICAL CORP PATIENT INTERFACE COMPUTER DQK WITT BIOMEDICAL CORP. FRONT END *

    Patients

    Seq Age Sex Outcome Treatment
    1 *