BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RA1000

    MDR report key: 1963733 · Received December 22, 2010

    Report

    Report Number
    3004526608-2010-00034
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    September 27, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K043415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE MONITOR MEASUREMENT TOOL IS NOT CORRECT. THERE WAS NO REPORTED PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RA1000 LLZ GE HEALTHCARE UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1