BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 4092836 · Received August 21, 2014

    Report

    Report Number
    2023446-2014-00132
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 18, 2013
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    FA-14002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BURNT PLASTIC ODOR WAS REPORTED FROM THE CENTRIFUGE. NO ONE WAS EXPOSED OR INJURED. NO SMOKE OR FIRES WERE OBSERVED. THE UNIT INSPECTION INDICATED THAT THE POWER CONNECTOR WAS WORN AT THE PCB AND PCB WAS DAMAGED. THE POWER HARNESS WAS REPLACED. THE FIRE DEPARTMENT WAS NOT CALLED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BURNING SMELL BUT INSTRUMENT WORKING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504568 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NI