BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX CS-2100I

    MDR report key: 8478205 · Received April 3, 2019

    Report

    Report Number
    1000515253-2019-00009
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    February 27, 2019
    Report Date
    August 22, 2019
    Manufacturer
    SYSMEX CORPORATION, I SQUARE
    Product Code
    JPA
    UDI-DI
    04987562409471
    PMA / PMN Number
    K162688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSMEX CS-2000I/2100I INSTRUCTIONS FOR USE (IFU), CHAPTER 2 - SAFETY INFORMATION, SECTION 2.2 - GENERAL INFORMATION WARNS THE USER: SHOULD THE INSTRUMENT EMIT ANY UNUSUAL ODORS OR SMOKE, TURN THE MAIN SWITCH OFF IMMEDIATELY AND UNPLUG THE POWER CABLE. CONTACT YOUR LOCAL TECHNICAL REPRESENTATIVE. THE USER APPROPRIATELY TURNED OFF THE ANALYZER, DISCONNECTED THE POWER, AND CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS. THE SE REPLACED THE MOTOR BLOCK NO. 126 ASSY. WITHOUT RESOLUTION. THE SE RETURNED TO THE CUSTOMER SITE AND REPLACED PCB NO. 1279, WHICH RESOLVED THE ISSUE. THE ANALYZER COVER AND MOTOR ENCODER DISC ARE MADE OF FLAME RESISTANT MATERIALS, BUT EXCESSIVE HEAT FROM A MALFUNCTION POSES A RISK OF INHALATION OF SMOKE AND/OR HARMFUL VAPORS FROM SCORCHED MATERIALS. THE AFFECTED PARTS ARE COVERED WITH A METAL SHEET AND NOT ACCESSIBLE TO THE USER, REDUCING POTENTIAL HARM. SYSMEX CORPORATION JAPAN (S-CORP) REQUESTED THE PARTS FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    SYSMEX CORPORATION (B)(4) (S-CORP) COMPLETED THE INVESTIGATION. S-CORP DETERMINED A SHORT CIRCUIT FROM EITHER THE PRINTED CIRCUIT BOARD (PCB) NO. 1279 OR THE STEPPING MOTOR (A COMPONENT OF MOTOR BLOCK ASSEMBLY NO. 126) CAUSED THE EVENT. THESE PARTS ARE CONNECTED; THEREFORE, S-CORP WAS UNABLE TO DETERMINE THE ORIGIN OF THE SHORT CIRCUIT. S-CORP DETERMINED THIS IS AN ISOLATED EVENT. THERE WAS NO SYSTEMIC DEFICIENCY IDENTIFIED, AS NO SIMILAR ISSUE WAS REPORTED. NO FURTHER CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    A USER IN (B)(6) REPORTED A BURNT ODOR EMANATING FROM THE ANALYZER. THE USER IMMEDIATELY TURNED OFF THE ANALYZER, DISCONNECTED THE POWER, AND CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS. A SIEMENS SERVICE ENGINEER (SE) WAS DISPATCHED THE SAME DAY AND FOUND THE CP UNIT DRIVE OF MOTOR BLOCK ASSEMBLY NO. 126 WAS BURNT, PARTS OF THE MOTOR ENCODER DISC WERE MELTED, A FUSE ON THE POWER SUPPLY (WIRING CORD NO. 5391) WAS BLOWN, AND PRINTED CIRCUIT BOARD (PCB) NO. 1279 WAS DAMAGED. SMOKE WAS OBSERVED; HOWEVER, NO OPEN FIRE WAS OBSERVED. NO USERS SOUGHT MEDICAL ATTENTION DUE TO THE BURNING ODOR. NO USER OR PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272324 SYSMEX CS-2100I AUTOMATED COAGULATION ANALYZER JPA SYSMEX CORPORATION, I SQUARE CS-2100I 04987562409471

    Patients

    Seq Age Sex Outcome Treatment
    1