BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGIQ E9

    MDR report key: 7396980 · Received April 4, 2018

    Report

    Report Number
    3005860720-2018-00001
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    December 5, 2017
    Report Date
    April 4, 2018
    Manufacturer
    SEE H10
    Product Code
    IYN
    PMA / PMN Number
    K163077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC, POWER CORD IDENTIFICATION: MODEL H4000ZA, CATALOG# 5148381. (B)(4). THE COMPLAINT INVESTIGATION CONCLUDED A PORTION OF THE SYSTEM-END OF THE POWER CORD SEPARATED DUE TO WEAR AND TEAR, AND IT CONFIRMED THE INJURY WAS MINOR. AT THAT TIME THE COMPLAINT INVESTIGATION WAS CONCLUDED. THEN IN MARCH OF 2018, A SEPARATE INVESTIGATION WAS PERFORMED FOR A REPORT OF A PORTION OF THE SYSTEM-END OF A POWER CORD SEPARATING UNEXPECTEDLY, AND FOR WHICH DID NOT RESULT IN AN INJURY/EVENT BECAUSE IT WAS NOT ENERGIZED. THE RESULTS OF THE SECOND INVESTIGATION CONCLUDE A PROBLEM WITH PROCESS CONTROL BY THE SUPPLIER OF THE POWER CORD, AND THE LIKELIHOOD OF HARM ASSOCIATED WITH THIS FAILURE IS UNLIKELY. A CORRECTIVE ACTION FOR THE ASSEMBLY PROCESS HAS BEEN INITIATED, AND QUALITY CONTROLS HAVE BEEN IMPLEMENTED.

    Description of Event or Problem · 1

    INTERNALLY TO GE, A PORTION OF THE SYSTEM-END OF A LOGIQ E9 POWER CORD HAD SEPARATED UNEXPECTEDLY WHILE ENERGIZED AND THE USER¿S FINGER CONTACTED AN ENERGIZED CONDUCTOR CAUSING A MINOR SHOCK RESULTING IN A MINOR BURN TO THE FINGER OF THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240740 LOGIQ E9 ULTRASONIC PULSED DOPPLER IMAGING SY IYN SEE H10 5205000-9 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0