BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSPIN SSMP CENTRIFUGE

    MDR report key: 5080627 · Received September 16, 2015

    Report

    Report Number
    2023446-2015-00234
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 26, 2015
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN PROVIDED A NEW BOARD AND MOTOR FOR THE CUSTOMER TO REPAIR THE UNIT. THE SYSTEM WAS NOT RETURNED TO MANUFACTURER FOR INSPECTION OR REPAIR. CUSTOMER REPAIRED THE UNIT ON SITE WITH PARTS SENT. THE ISSUE WAS RESOLVED WITH THEIR REPAIR. THE BECKMAN COULTER (BEC) INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4). NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN BURNING SMELL FROM THEIR STATSPIN SSMP CENTRIFUGE DURING OPERATION. THE CUSTOMER COULD NOT CONFIRM IF THERE WERE SMOKE OR FIRES, BUT STATES IT WAS REPORTED THERE WAS AN ELECTRICAL BURNING ODOR. THERE WERE NO REPORTS OF DELAY TO SAMPLE PROCESSING. THERE WERE NO REPORTS OF INJURIES, NO DIRECT EXPOSURE AND NO MEDICAL ATTENTION WAS SOUGHT. THE CUSTOMER INDICATED THEY HAD REPLACED THE MOTOR ON THE UNIT JUST BEFORE THE EVENT. THE CUSTOMER INDICATED THEY ALSO SAW A WRENCH LIGHT ROTOR ERROR. THE CUSTOMER STARTED THE CYCLE AGAIN AND SMELLED THE BURNING SMELL. THE CUSTOMER OPENED THE UNIT AND OBSERVED THE PRINTED CIRCUIT BOARD (PCB) WAS BURNED AND ALSO OBSERVED THE BOARD WAS CHARRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612668 STATSPIN SSMP CENTRIFUGE STATSPIN SSMP CENTRIFUGE JQC IRIS INTERNATIONAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1