BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIDIAGNOST CONVENTIONAL

    MDR report key: 2013406 · Received February 2, 2011

    Report

    Report Number
    3003768277-2011-00093
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    January 6, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JAA
    PMA / PMN Number
    K904012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT IS STILL UNDER INVESTIGATION. THE F/U REPORT WILL BE SENT BY (B)(4) 2011.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE GENERATOR TURNS ITSELF OFF DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIDIAGNOST CONVENTIONAL NONE JAA PHILIPS HEALTHCARE 708024

    Patients

    Seq Age Sex Outcome Treatment
    1