BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA-560

    MDR report key: 7664571 · Received July 5, 2018

    Report

    Report Number
    1000515253-2018-00010
    Event Type
    Malfunction
    Date Received
    July 5, 2018
    Date of Event
    June 5, 2018
    Report Date
    October 19, 2018
    Manufacturer
    SYSMEX RA CO. LTD.
    Product Code
    JPA
    UDI-DI
    04987562129294
    PMA / PMN Number
    K992763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT PRINTER WAS INSPECTED BY SYSMEX CORPORATION JAPAN (S-CORP). IT WAS CONFIRMED THE PLASTIC PARTS OF THE PRINTER MELTED AND DEFORMED. S-CORP INSPECTED THE FLAMMABILITY OF PARTS AROUND THE CA-560 PRINTER AND CONFIRMED THAT THE PRINTER IS ENCLOSED WITH FLAME RETARDANT MATERIAL. IT WAS ALSO CONFIRMED THAT THE PRINTER UNIT IS UL CERTIFIED AND THEREFORE THE CA-560 WILL NOT BURN EVEN IF ABNORMAL HEATING OCCURS IN THE PRINTER. S-CORP CONDUCTED TESTS TO ATTEMPT TO REPRODUCE PRINTER OVERHEATING DUE TO EXTERNAL FACTORS. TESTS PERFORMED DID NOT REPRODUCE THE EVENT. TESTS WERE ALSO PERFORMED TO DETERMINE IF THE PAPER WITHIN THE PRINTER COULD IGNITE. TESTS PERFORMED DID NOT GENERATE COMBUSTION. THE PRINTER WAS SENT TO THE MANUFACTURER OF THE PRINTER, FUJITSU COMPONENT LIMITED, FOR FURTHER INVESTIGATION. THE MANUFACTURER REPORTED THAT THE THERMAL HEAD INSIDE THE PRINTER WAS BROKEN AND THE HEAT RESISTOR IN THE THERMAL HEAD HAD SWELLED. NO ABNORMALITY WAS FOUND IN THE DRIVER INTEGRATED CIRCUIT (IC) OF THE THERMAL HEAD AND THE MOTOR. THEREFORE, IT IS ASSUMED THAT EXCESSIVE ENERGY WAS APPLIED TO THE HEAT RESISTOR IN THE THERMAL HEAD. IT WAS NOT POSSIBLE TO REPRODUCE THE ISSUE AND S-CORP WAS UNABLE TO DETERMINE AN EXACT ROOT CAUSE FOR THE "EXCESSIVE ENERGY", AND THERE ARE NO SIMILAR OCCURRENCES OF THIS EVENT. THE CONCLUSION WAS THAT THIS WAS AN INDIVIDUAL FAILURE OF THE PRINTER DUE TO THE EXCESSIVE ENERGY TO THE THERMAL HEAD, AND NOT DUE TO THE DESIGN OF THE CA-500 SERIES OR PRINTER. AN EVALUATION OF POTENTIAL HARM TO THE OPERATOR DUE TO A POSSIBLE INJURY IF ATTEMPTING TO CHANGE THE ROLL OF THERMAL PAPER IF THE EVENT RE-OCCURRED WAS PERFORMED BY S-CORP. IT WAS DETERMINED THAT IF THE EVENT WERE TO RE-OCCUR THERE WOULD NOT BE A POTENTIAL BURN INJURY BECAUSE, THE PRINTER HEAD (WHERE THE EXCESSIVE HEAT IS BEING GENERATED FROM) IS INSIDE OF THE ANALYZER AND INACCESSIBLE TO THE USER. NO COUNTERMEASURES TO THE CA-560 OR PREVENTIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    THE SYSMEX CA-560 INSTRUCTIONS FOR USE (IFU). CHAPTER 2 - SAFETY INFORMATION, 2.2 - GENERAL INFORMATION, WARNS THE USER: "IN THE EVENT THAT THE INSTRUMENT EMITS AN ABNORMAL ODOR OR ANY SMOKE, TURN OFF ITS POWER SUPPLY IMMEDIATELY AND PULL OUT THE POWER PLUG FROM THE WALL SOCKET". THE SUSPECT PRINTER ASSEMBLY WAS RETURNED TO SYSMEX CORPORATION (B)(4) (S-CORP) FOR INVESTIGATION. INVESTIGATION REGARDING ROOT CAUSE DETERMINATION IS ONGOING. ANY INCIDENT WITH EXCESSIVE HEAT HAS THE POTENTIAL TO CAUSE USER HARM. THE INTERNAL PRINTER IS MADE OF FLAME RESISTANT MATERIALS AND COVERED WITH A PLASTIC PANEL BUT, EXCESSIVE HEAT FROM THE EVENT POSES A RISK OF PHYSICAL HARM.

    Description of Event or Problem · 1

    THE USER REPORTED A BURNING PLASTIC ODOR EMANATING FROM THE ANALYZER'S INTERNAL PRINTER. THERE WAS NO FIRE, FLAMES OR SMOKE REPORTED. THE USER IMMEDIATELY TURNED THE INSTRUMENT OFF AND THERE WAS NO REPORT OF INJURY OR HARM TO THE USER. IT WAS REPORTED THAT THE PRINTER PAPER HAD BURN MARKS. A CUSTOMER SERVICE ENGINEER (CSE) REPLACED THE SUSPECT PRINTER ASSEMBLY TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506909 CA-560 AUTOMATED COAGULATION ANALYZER JPA SYSMEX RA CO. LTD. CA-560 04987562129294

    Patients

    Seq Age Sex Outcome Treatment
    1