BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UDM-IPU

    MDR report key: 19645849 · Received July 1, 2024

    Report

    Report Number
    1000515253-2024-00005
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 1, 2024
    Report Date
    February 27, 2025
    Manufacturer
    SYSMEX AMERICA INC.
    Product Code
    OUG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE ENGINEER (SE) WAS DISPATCHED AND EXAMINED THE IPU. THE SE FINDINGS SUGGEST THE SOURCE OF THE FIRE TO BE EXTERNAL DUE TO THE INTERNAL IPU COMPONENTS NOT SHOWING EVIDENCE OF HEAT DAMAGE. THE PRINTER CABLE PLUG CONNECTED TO THE UNIVERSAL SERIAL BUS (USB) PORT ON THE BACK OF THE SUSPECT IPU, HOWEVER APPEARED COMPLETELY BURNED. NO SERVICE EVENT OR REARRANGEMENT OF THE CABLES WAS PERFORMED PRIOR TO THE OCCURRENCE OF THE EVENT. THE SUSPECT IPU AND THE SUSPECT CABLE HAVE BEEN REQUESTED FOR RETURN TO THE IPU SUPPLIER, CONTEC, FOR A FAILURE ROOT CAUSE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE FAILURE OF THE SUSPECT INTERNAL PROCESSING UNIT (IPU) WAS INVESTIGATED BY THE 3RD PARTY MANUFACTURER, CONTEC. INVESTIGATION DISCOVERED THE FOLLOWING SIGNS OF ELECTRICAL DAMAGE: A SMALL SECTION OF THE MOTHERBOARD WAS BURNT. ONE OF THE USB PORTS WAS BURNT. PER CONTEC, OBSERVED DAMAGE WAS LIKELY CAUSED BY EITHER A CONNECTED DEVICE PULLING TOO MUCH CURRENT OR AN INFLUX OF ELECTRICAL CURRENT, CAUSING THE CHIPSET ON THE MOTHERBOARD TO FAIL. PER CONTEC, THE IPUS ARE DESIGNED AND TESTED TO COMPLY WITH INTERNATIONALLY RECOGNIZED SAFETY STANDARDS, PARTICULARLY UL/CSA 62368-1, WHICH EXPLICITLY FOCUSES ON ENSURING ELECTRICAL AND ELECTRONIC EQUIPMENT, INCLUDING COMPUTERS, ARE FIRE-SAFE. THE UL/CSA 62368-1 STANDARD INTEGRATES ROBUST SAFETY PRINCIPLES, INCLUDING: MATERIAL SELECTION: THE COMPONENTS AND ENCLOSURES OF THE COMPUTERS ARE MADE OF FIRE-RETARDANT MATERIALS. THESE MATERIALS ARE TESTED TO SELF-EXTINGUISH WITHIN A SPECIFIC TIME FRAME IF EXPOSED TO FLAMES, PREVENTING FIRE FROM SPREADING. FAULT TESTING: DEVICES ARE SUBJECTED TO RIGOROUS TESTS TO SIMULATE ELECTRICAL FAULTS THAT COULD LEAD TO OVERHEATING OR FIRE. PROTECTIVE BARRIERS: THE COMPUTERS INCORPORATE PHYSICAL INSULATION BARRIERS AND FIRE ENCLOSURES TO CONTAIN ANY POTENTIAL FIRE WITHIN THE DEVICE. INTERNAL COMPONENTS SUCH AS POWER SUPPLIES AND TRANSFORMERS HAVE BUILT-IN FIRE CONTAINMENT FEATURES. THERMAL MANAGEMENT: EFFECTIVE HEAT DISSIPATION IS ENSURED THROUGH PROPER VENTILATION, HEAT SINKS, AND FANS, REDUCING THE LIKELIHOOD OF OVERHEATING AND SUBSEQUENT FIRE RISK. ROOT CAUSE OF THE FIRE EVENT COULD NOT BE IDENTIFIED PER THE IPU MANUFACTURER, CONTEC. NOTE: H6: INVESTIGATION CONCLUSION (D): "CODE 4613: APPROPRIATE TERM/CODE NOT AVAILABLE" WAS USED. DESIRED NEW CODE: "THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED EVENT."

    Description of Event or Problem · 0

    THE USER REPORTED THAT THE INTERNAL PROCESSING UNIT (IPU) OF THE URINALYSIS DATA MANAGER (UDM) HAD CAUGHT ON FIRE. NO HARM OR INJURY TO ANY OPERATOR WAS REPORTED. THIS EVENT IS BEING REPORTED TO THE FDA FOR THE POTENTIAL FOR SERIOUS INJURY IF THIS ISSUE WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571319 UDM-IPU UDM-IPU OUG SYSMEX AMERICA INC. UDM-IPU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown