BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFUGE 20R

    MDR report key: 4816304 · Received June 3, 2015

    Report

    Report Number
    3007448124-2015-00003
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 12, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVISION OF THE FILED MDR, THE PRODUCT CODE WAS CHANGED FROM KSO TO JQC.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE ON (B)(6) 2015. THE FSE RAN THE INSTRUMENT AND THE DISPLAY WAS NOT FUNCTIONING. THE FSE DETERMINED THAT THE POWER BOARD FAILED AND NEEDED TO BE REPLACED. THE CAPACITOR ON THE POWER BOARD SHORTED RESULTING IN A CHARRED CIRCUIT BOARD. A REPLACEMENT BOARD WAS ORDERED BY THE FSE TO HELP THE CUSTOMER RESOLVE THE ISSUE. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BURNING SMELL COMING FROM A MICROFUGE 20R BENCH TOP CENTRIFUGE WHILE RUNNING THE INSTRUMENT, AND REQUESTED A SERVICE VISIT. THERE WAS NO AFFECT TO SAMPLE PROCESSING OR PATIENT RESULTS REPORTED IN CONNECTION WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358906 MICROFUGE 20R BENCH TOP CENTRIFUGE JQC BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1