BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RA1000

    MDR report key: 3042989 · Received March 7, 2013

    Report

    Report Number
    3004526608-2013-00001
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 8, 2013
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K110875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MEASUREMENT OBTAINED FROM THE RA1000 IS NOT THE SAME MEASUREMENT THAT IS OBTAINED FROM THE SIEMENS MODALITY. THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98369 RA1000 LLZ GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1