BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 4030375 · Received July 29, 2014

    Report

    Report Number
    2023446-2014-00099
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    IRIS DIAGNOSTICS
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE EXPRESS 4 UNIT SMELLING BURNT PLASTIC ODOR. CUSTOMER FOUND EVIDENCE OF CHARRING AND BLACK DISCOLORATION AT THE CONNECTOR TO THE PCB. THERE WAS NO EVIDENCE OF FIRES OR SMOKE AND NO ONE WAS INJURED OR HAD TO BE TREATED. THERE WERE NO REPORTS OF OPEN FLAMES, SMOKE EMISSION AND FIRE DEPARTMENT WAS NOT CALLED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POWER HARNESS CONNECTOR CHARRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442670 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1