BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIQ E9 BREAKTHROUGH 2011

    MDR report key: 10438127 · Received August 21, 2020

    Report

    Report Number
    3005860720-2020-00004
    Event Type
    Injury
    Date Received
    August 21, 2020
    Date of Event
    July 8, 2020
    Report Date
    September 24, 2020
    Manufacturer
    GE MEDICAL SYSTEMS ULTRASOUND &
    Product Code
    IYN
    PMA / PMN Number
    K163077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GEHC'S INVESTIGATION HAS COMPLETED. THE EVENT IS AN ALLEGATION BY THE CUSTOMER OF EXACERBATION OF AN EXISTING MSK INJURY (KNEE INJURY) OF A SONOGRAPHER WHO MOVED THE LOGIQ E9 SCANNER WHILE TURNING A CORNER. GEHC EVALUATED THE LOGIQ E9 AND FOUND NO MALFUNCTION OF THE DEVICE. ADDITIONALLY, THE COMPLAINT FILE WAS SEARCHED FOR OTHER REPORTS OF THE SAME AND/OR SIMILAR EVENTS AND NO OTHER RECORDS WERE FOUND. THE RISK EVALUATION CONCLUDED PROPER MITIGATIONS ARE IN PLACE, AND NO FURTHER ACTION IS BEING PERFORMED.

    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. A GEHC SERVICE REPRESENTATIVE EVALUATED THE EQUIPMENT AND GEHC'S INVESTIGATION IS ONGOING. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    A GEHC SERVICE REPRESENTATIVE WAS MADE AWARE FROM A CUSTOMER THAT AN ULTRASOUND TECHNICIAN INJURED THEIR KNEE WHILE MOVING THE PORTABLE ULTRASOUND SYSTEM, THE LOGIQ E9. THE CUSTOMER PROVIDED ADDITIONAL INFORMATION STATING THE INJURY OCCURRED AFTER THE TECHNICIAN PERFORMED A PORTABLE EXAM ON THE LABOR AND DELIVERY UNIT. THE EMPLOYEE STATED THAT THEY WERE TRANSPORTING THE LOGIQ E9 FROM THE MONITOR HANDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902800 LOGIQ E9 BREAKTHROUGH 2011 SYSTEM, IMAGING, PULSED DOPPLER, ULT IYN GE MEDICAL SYSTEMS ULTRASOUND & UGLG9L 00000123788US2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other