BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIQ E9

    MDR report key: 8554991 · Received April 26, 2019

    Report

    Report Number
    3005860720-2019-00001
    Event Type
    Injury
    Date Received
    April 26, 2019
    Date of Event
    January 28, 2017
    Report Date
    September 3, 2019
    Manufacturer
    SEE H10
    Product Code
    IYN
    PMA / PMN Number
    K123564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GES INVESTIGATION HAS COMPLETED. THE ACTUAL LOGIQ E9 COULD NOT BE EVALUATED, AND ADDITIONAL INFORMATION COULD NOT BE OBTAINED FROM THE CUSTOMER. THEREFORE, THE ROOT CAUSE OF THE INJURY COULD NOT DEFINITIVELY BE REACHED. THEREFORE, THE INVESTIGATION TURNED TO HISTORICAL COMPLAINT DATA BOTH ON THE ACTUAL DEVICE AND THE COMPLAINT FILE. THE LAST SERVICE RECORD GE HAS ON THE LOGIQ E9 ALLEGED TO BE INVOLVED IN THE INJURY WAS FROM (B)(6) 2015, WHICH IS APPROXIMATELY TWO YEARS PRIOR TO THE INJURY. A REVIEW OF THE COMPLAINT FILE FOUND NO OTHER RELATED INCIDENTS IN A FOUR-YEAR PERIOD. THEREFORE, IT HAS BEEN CONCLUDED THAT NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NO REPORT OF PATIENT INVOLVEMENT, THIS IS A USER INJURY. LEGAL MANUFACTURER NAME IS GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC. DEVICE MANUFACTURED IN 2013, UDI NOT REQUIRED. GE IS CURRENTLY ATTEMPTING AN INVESTIGATION OF THE EVENT.

    Description of Event or Problem · 1

    GE HEALTHCARE INTERNAL COUNSEL RECEIVED NOTICE OF A LAWSUIT FROM SOMEONE WHO ALLEGES SHE WAS A FORMER USER OF THE ULTRASOUND DEVICE. THE PLAINTIFF IN THE LAWSUIT ALLEGES THAT ON OR ABOUT (B)(6) 2017 WHILE PHYSICALLY RAISING THE KEYBOARD AND MONITOR ON THE ULTRASOUND, SHE SUFFERED SEVERE AND PERMANENT INJURIES TO HER RIGHT SHOULDER AND SCAPULAR MUSCLE. NO FURTHER DETAILS HAVE BEEN PROVIDED TO GE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349038 LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM IYN SEE H10 ULOE9Y 123630US6

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability