BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTEGRA RPFA-TRAP

    MDR report key: 583568 · Received March 11, 2005

    Report

    Report Number
    2031760-2005-00001
    Event Type
    Malfunction
    Date Received
    March 11, 2005
    Date of Event
    January 25, 2005
    Manufacturer
    ACCUMETRICS
    Product Code
    JOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE ULTEGRA ANALYZER, ITS PRINTER, AND THE PRINTER POWER SUPPLY WERE INVOLVED IN A FIRE IN THE HOSP'S CARDIAC CATHETERIZATION LAB. THE FIRE OCCURRED AFTER HOURS (APPROXIMATELY 9-10 PM), WHEN THE LAB WAS NOT IN USE. NO HOSP PERSONNEL OR PTS WERE PRESENT AT THE TIME OF THE FIRE. HOSP PERSONNEL WERE ALERTED BY AN ALARM, AND THE FIRE WAS EXTINGUISHED. THE FIRE WAS LIMITED TO A SMALL AREA WHERE THE ULTEGRA, PRINTER, TESTING SUPPLIES, AND ANOTHER SMALL INSTRUMENT WERE LOCATED. SMOKE WAS OBSERVED IN THE CATH LAB. NO ONE WAS INJURED BY THE FIRE OR SMOKE. IT IS NOT KNOWN HOW THE FIRE STARTED, BECAUSE NO ONE WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTEGRA RPFA-TRAP PLATELET FUNCTION ASSAY JOZ ACCUMETRICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *