BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY MR750W 3.0T

    MDR report key: 10548949 · Received September 17, 2020

    Report

    Report Number
    2183553-2020-00014
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 21, 2020
    Report Date
    September 17, 2020
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K160618
    Removal / Correction Number
    2183553-06/13/18-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVED IN THIS EVENT. THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. UNIQUE IDENTIFIER: (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? UNKNOWN. GE HEALTHCARE'S INVESTIGATION HAS DETERMINED THAT THE CABLE MODE PRESENT IN THE DESIGN OF THE MR750W RF BODY COIL IS THE ROOT CAUSE OF ARCING THAT HAS LED TO EXCESS HEAT/DISCOLORATION OF THE SURFACE OF THE PATIENT BORE. GE HEALTHCARE IS INITIATING AN ACTION IN THE FIELD TO INSPECT UNITS TO DETERMINE WHICH UNITS HAVE THE POTENTIAL CABLE MODE, AND MAKE ANY CORRECTIONS IF NECESSARY. THIS ACTION WAS REPORTED TO THE FDA UNDER CORRECTION NUMBER 2183553-06/13/18-002-C ON (B)(6) 2018. COMPONENT CODE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER CALLED FOR SERVICE AFTER NOTICING A BROWN SPOT ON THE BORE AT THE COMPLETION OF AN EXAM. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009821 DISCOVERY MR750W 3.0T NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1