BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACS IW

    MDR report key: 2260235 · Received August 31, 2011

    Report

    Report Number
    3004526608-2011-00035
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Report Date
    August 1, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K072986
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SITE REPORTS THAT WHEN INSERTING KEY IMAGES WITH PRIORS, THE DATE ON THE KEY IMAGES ONLY REFLECTS THE DATE OF THE CURRENT IMAGES AND NOT THE PRIOR DATE. THERE WAS NO REPORTED PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1