BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX POCH-100I

    MDR report key: 7830713 · Received August 29, 2018

    Report

    Report Number
    1000515253-2018-00013
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    July 30, 2018
    Report Date
    February 25, 2019
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKL
    UDI-DI
    04987562401994
    PMA / PMN Number
    K032677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PCB IS MADE OF FLAME RESISTANT MATERIALS, BUT EXCESSIVE HEAT FROM THE MALFUNCTION POSES A RISK OF INHALATION OF SMOKE AND/OR HARMFUL VAPORS FROM SCORCHED MATERIALS. THE PCB IS NOT ACCESSIBLE TO THE USER, AND IS GROUNDED, REDUCING THE POTENTIAL FOR HARM DUE TO SHOCK. INVESTIGATION FOR ROOT CAUSE IS ONGOING BY SYSMEX CORPORATION (B)(4).

    Additional Manufacturer Narrative · 1

    THE SYSMEX POCH-100I INSTRUCTIONS FOR USE (IFU), CHAPTER 7 - SAFETY INFORMATION & WASTE DISPOSAL, SECTION 7.1 SAFETY INFORMATIONS, WARNS THE USER: "IF THE INSTRUMENT EMITS UNUSUAL ODORS OR SMOKE, OR IF THE INSTRUMENT LEAKS: SWITCH OFF IMMEDIATELY AND UNPLUG THE POWER CABLE. CONTACT YOUR SYSMEX SERVICE REPRESENTATIVE." THE USER IMMEDIATELY DISCONNECTED THE POWER. SYSMEX CORPORATION (B)(4) (S-CORP) PERFORMED THE INVESTIGATION. S-CORP IDENTIFIED THE DC/DC CONVERTER MOUNTED ON THE LIQUID CRYSTAL DISPLAY (LCD) CONTROL BOARD (PCB NO. (B)(4)) FAILED, AND REQUESTED AN INVESTIGATION FROM THE SUPPLIER OF THE PCB. DUE TO THE CHARRING OF PCB NO. (B)(4), INVESTIGATION WAS IMPOSSIBLE. ROOT CAUSE WAS UNDETERMINED. S-CORP REPLACED THE ANALYZER. PCB NO. (B)(4) IS NOT ACCESSIBLE TO THE USER, AND IS GROUNDED, REDUCING THE POTENTIAL FOR HARM DUE TO SHOCK. THE PCB IS MADE OF FLAME RESISTANT MATERIALS AND COVERED WITH A METAL SHIELD.

    Description of Event or Problem · 1

    A USER IN (B)(6) DETECTED A BURNING ODOR EMANATING FROM THE ANALYZER AFTER TURNING THE POWER ON. THE USER IMMEDIATELY DISCONNECTED THE POWER. A SERVICE ENGINEER WAS DISPATCHED AND FOUND A BURNT PRINTED CIRCUIT BOARD (PCB). NO USERS SOUGHT MEDICAL ATTENTION DUE TO THE BURNING ODOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666620 SYSMEX POCH-100I AUTOMATED HEMATOLOGY ANALYZER GKL SYSMEX CORPORATION POCH-100I 04987562401994

    Patients

    Seq Age Sex Outcome Treatment
    1