BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 3901708 · Received May 5, 2014

    Report

    Report Number
    2023446-2014-00049
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 9, 2014
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STATSPIN VET EXPRESS CENTRIFUGE DEVICE REPORTED FLAMES FROM INSIDE AND SMOKE DURING OPERATION. NO INJURIES WERE REPORTED. BURNING SMELL REMAINED FOR DAYS AFTER INCIDENT. NO CHARRED MATERIAL REPORTED AND FIRE DEPARTMENT WAS NOT CALLED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A STATSPIN VET EXPRESS UNIT CAUGHT FIRE FROM INSIDE DURING THE CYCLE SPIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268342 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1