BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 3902445 · Received May 6, 2014

    Report

    Report Number
    2023446-2014-00052
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STATSPIN CENTRIFUGE HAD 120VAC AT 24V PS IN AND 24VDS AT 24VPS OUT, BUT THERE WAS NO LIGHTS ON THE PANEL. IT WAS DETERMINED THAT POWER HARNESS AT CONTROL BOARD WAS BURNED. NO INJURIES REPORTED. NO VISIBLE FLAMES, SMOKE OR BURNING SMELL REPORTED, NOR WAS FIRE DEPT CALLED, BUT CHARRED MATERIAL PRESENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO 120VAC AT 24VPS IN AND 24VDC AT 24VPS OUT, BUT THERE WERE NO LIGHTS ON THE PANEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272126 EXPRESS 4 STATSPIN SENTRIFUGE JQC IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1