BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAGNOST 97 - MCP/SCP - DSI

    MDR report key: 2012218 · Received February 1, 2011

    Report

    Report Number
    3003768277-2011-00086
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Report Date
    January 4, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JAA
    PMA / PMN Number
    K912470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA BY 04/02/2011.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RADIATION DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAGNOST 97 - MCP/SCP - DSI JAA PHILIPS HEALTHCARE 70853

    Patients

    Seq Age Sex Outcome Treatment
    1