BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGIQ E9 BREAKTHROUGH 2011

    MDR report key: 18219625 · Received November 28, 2023

    Report

    Report Number
    3005860720-2023-00006
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    October 29, 2023
    Report Date
    January 25, 2024
    Manufacturer
    GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAG
    Product Code
    IYN
    PMA / PMN Number
    K110943
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4, UDI: UDI NOT REQUIRED, DEVICE IS PRE-COMPLIANCE, LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226. GE HEALTHCARE'S INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    GE HEALTHCAREÂS INVESTIGATION HAS COMPLETED. THE LOGIQ E9 WAS SENT TO A THIRD PARTY FOR EVALUATION. THE EVALUATION CONCLUDED THE POWER CORD PLUG AT THE LOGIQ E9 SIDE OF THE CORD BROKE DOWN CAUSING EXCESSIVE CURRENT FLOW BETWEEN WIRES WHICH LED TO EXCESSIVE HEATING RESULTING IN THE FIRE. DUE TO THE DAMAGE, GE HEALTHCARE WAS UNABLE TO DETERMINE IF THE DEFECT WAS A RESULT OF WEAR & TEAR OR IF THERE WAS POTENTIALLY A MANUFACTURING DEFECT. THEREFORE, A FURTHER REVIEW OF THE POWER CORD COMPLAINT HISTORY AND MANUFACTURING DATA WAS CONDUCTED, AND IT WAS CONCLUDED THAT THERE IS NEITHER A DESIGN DEFECT NOR MANUFACTURING ISSUE. THE RISK ASSESSMENT CONCLUDED AVAILABLE MITIGATIONS ARE VERIFIED TO BE EFFECTIVE AND ARE ANTICIPATED TO REDUCE THE RISK OF THIS HAZARDOUS SITUATION AS FAR AS POSSIBLE (AFAP). NO FURTHER ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    ON 10-29-2023 GE HEALTHCARE RECEIVED A REPORT THAT A LOGIQ E9 ULTRASOUND EXPERIENCED AN ALLEGED ELECTRICAL FAILURE RESULTING IN MELTING, BURNING AND FIRE AT THE CUSTOMER SITE. NO PATIENTS OR USERS WERE PRESENT IN THE ROOM WHEN THE EVENT OCCURRED, AND NO INJURIES WERE REPORTED. THE FIRE RESULTED IN PROPERTY DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524135 LOGIQ E9 BREAKTHROUGH 2011 DIAGNOSTIC ULTRASOUND IMAGING SYS IYN GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAG ULOE9T 110264US9

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown