BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 4235065 · Received September 5, 2014

    Report

    Report Number
    2023446-2014-00145
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 13, 2013
    Manufacturer
    IRIS DIAGNOSTICS
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    FA-14002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED EXPRESS 4 CENTRIFUGE WOULD NOT OPERATE. UPON INSPECTION, THE POWER HARNESS WAS FOUND TO BE CHARRED ON THE PC BOARD. THERE WERE NO REPORTS OF BURNING SMELL, VISIBLE FLAMES, OR SMOKE EMISSION, AND FIRE DEPARTMENT WAS NOT CALLED. THERE WERE NO REPORTED EXPOSURES, INJURIES OR MEDICAL ATTENTION REQUIRED AND NO AFFECTS TO SAMPLE PROCESSING OR DELAYS TO PT TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE UNIT HAD NO POWER AND THE POWER HARNESS CHARRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543760 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1