BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI DIAGNOST 4

    MDR report key: 1994278 · Received January 14, 2011

    Report

    Report Number
    3003768277-2011-00023
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Report Date
    December 15, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JAA
    PMA / PMN Number
    K961374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT IS STILL UNDER INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT BY (B)(4) 2011.

    Description of Event or Problem · 1

    THE SYSTEM IS GOING THROUGH A REBOOT WHEN A MIDDLE OF THE PROCEDURE WITHOUT ANY ERROR MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI DIAGNOST 4 JAA PHILIPS HEALTHCARE 708031

    Patients

    Seq Age Sex Outcome Treatment
    1