BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON S1000

    MDR report key: 19843996 · Received July 26, 2024

    Report

    Report Number
    3023245-2024-00040
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 22, 2024
    Report Date
    October 22, 2024
    Manufacturer
    SIEMENS HEALTHINEERS
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS ONGOING AT SIEMENS HEALTHINEERS TO IDENTIFY THE ROOT CAUSE OF THE ISSUE. THE REPORT WILL BE SUPPLEMENTED AFTER THE INVESTIGATION IS COMPLETED. REFERENCE# (B)(4).

    Additional Manufacturer Narrative · 0

    THE DAMAGED POWER CORD WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, NO INVESTIGATION OF THE POWER CORD COULD BE PERFORMED. THE FACILITY REPLACED THE DAMAGED OUTLET. IT HAS BEEN ESTABLISHED THAT PLUGGING THE ULTRASOUND SYSTEM INTO A DAMAGED OUTLET RECEPTACLE CREATES INCREASED RESISTANCE IN THE LINE, NEUTRAL, AND GROUND CONDUCTORS. OVER TIME THE INCREASED RESISTANCE LEADS TO INCREASED TEMPERATURES IN THE POWER CORD CONDUCTORS AND OUTLET RECEPTACLES WHICH DEGRADES THE MATERIAL PROPERTIES OF THE CONDUCTORS. EVENTUALLY THE EFFECTIVE CURRENT CARRYING CROSS-SECTIONAL AREA OF THE LINE CONDUCTOR DUE TO DEGRADATION WILL BE REDUCED SUCH AS THAT THE CONDUCTOR CAN NO LONGER EFFECTIVELY CARRY THE CURRENTS PRESENT IN NORMAL OPERATION AND SYMPTOMS LIKE ARCING, MELTING, BURNING, AND FIRE CAN OCCUR. (EXAMPLE, THE CONDUCTOR STARTS AS A 14 AWG CONDUCTOR BUT THROUGH REPEATED USE IN A DAMAGED OUTLET THAT IMPACTS THE CONTACT OF THE CONDUCTORS IN THE CORD TO THE RECEPTACLE BEGINS TO PERMANENTLY DAMAGE THE CONDUCTOR, SO IT ONLY HAS ENOUGH "GOOD" MATERIAL LEFT TO BASICALLY BE AN UNDERSIZED 24 AWG CONDUCTOR LEADING TO EVEN MORE HEAT AND FIRE). THE DAMAGED POWER CORD WAS REPLACED AND ELECTRICAL SAFETY CHECK HAS BEEN COMPLETED. THE SYSTEM IS FULLY OPERATIONAL. IT IS RECOMMENDED THAT THE ULTRASOUND POWER CORD SHOULD NOT BE POSITIONED AGAINST ITEMS, SUCH AS WALLS OR BEDS, THAT WILL CAUSE PRESSURE ON THE CONNECTED POWER CORD AND OUTLET RECEPTACLE. DO NO CONTINUE TO USE ANY POWER CORD THAT SHOWS SIGNS OF MECHANICAL DAMAGE. REFERENCE# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYSTEM POWER CORD CAUGHT FIRE AND WAS EXTINGUISHED WITH A FIRE EXTINGUISHER. THERE WERE NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586449 ACUSON S1000 ULTRASOUND DEVICE IYN SIEMENS HEALTHINEERS ACUSON S1000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention