BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIDIAGNOST ELEVA

    MDR report key: 3912095 · Received May 13, 2014

    Report

    Report Number
    3003768277-2014-00050
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Report Date
    April 14, 2014
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K050151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM A CUSTOMER THAT THE SYSTEM WAS NOT READY FOR OPERATION. THE PROBLEM COULD BE A SHORT-CIRCUIT INT HE MONITOR POWER SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285096 MULTIDIAGNOST ELEVA IZI PHILIPS HEALTHCARE 708037

    Patients

    Seq Age Sex Outcome Treatment
    1