BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RA600

    MDR report key: 2160946 · Received June 16, 2011

    Report

    Report Number
    3004526608-2011-00019
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Report Date
    April 6, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K063628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BECAUSE OF A GAP IN THE DIGITAL DICTAPHONE, THE IMPORT WORD "NO" WAS OMITTED BEFORE THE SENTENCE "SUSPECTED METASTATIC CHANGES WITH WASH OUT". THIS WAS DISCOVERED WHEN SIGNING THE REPORT THE FOLLOWING DAY, AND COULD BE CORRECTED WITHOUT ANY CONSEQUENCE ON THE CARE DECISIONS. THERE WAS NO REPORTED PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RA600 LLZ GE HEALTHCARE UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1