BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX SA-10

    MDR report key: 6665599 · Received June 23, 2017

    Report

    Report Number
    1000515253-2017-00027
    Event Type
    Malfunction
    Date Received
    June 23, 2017
    Date of Event
    March 17, 2017
    Report Date
    June 23, 2017
    Manufacturer
    SYSMEX RA CO. LTD.
    Product Code
    JRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION BY SYSMEX CORPORATION IN (B)(4) DETERMINED LIGHTNING CAUSED AN EXCESSIVE VOLTAGE THAT EXCEEDED THE PRODUCT STANDARD TO BE APPLIED TO THE POWER SUPPLY UNIT. THE SURGE ABSORBER OF THE BOARD WAS DAMAGED. THERE WAS NO ABNORMALITY FOUND IN THE MANUFACTURING OF THE PRODUCT. THE BOARD WAS REPLACED AND THE INSTRUMENT WAS OPERATIONAL. ANY INCIDENT WITH EXCESSIVE HEAT HAS THE POTENTIAL TO CAUSE USER HARM. THE PCB IS MADE OF FLAME RESISTANT MATERIALS AND COVERED WITH A METAL SHIELD, BUT EXCESSIVE HEAT FROM THE EVENT POSES A RISK OF INHALATION OF SMOKE AND/OR HARMFUL VAPORS FROM MELTED MATERIALS. THE PCB IS NOT ACCESSIBLE TO THE USER, AND IS GROUNDED, REDUCING THE POTENTIAL FOR HARM DUE TO SHOCK.

    Description of Event or Problem · 1

    THE USER REPORTED A POWER OUTAGE OCCURRED OVER A WEEKEND WHEN THE LABORATORY WAS CLOSED. WHEN THE USER TURNED ON THE ANALYZER MONDAY MORNING, THE SAMPLER WAS NOT FUNCTIONING. A SYSMEX FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND FOUND THE SURGE ABSORBER ON THE PRINTED CIRCUIT BOARD (PCB) POWER SUPPLY WAS CHARRED DUE TO EXCESSIVE HEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443575 SYSMEX SA-10 SA-10 SAMPLER UNIT JRO SYSMEX RA CO. LTD. SA-10

    Patients

    Seq Age Sex Outcome Treatment
    1