BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 3960335 · Received June 23, 2014

    Report

    Report Number
    3003768277-2014-00067
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Report Date
    May 26, 2014
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR# (B)(4). WHEN INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM A CUSTOMER THAT THE SYSTEM SHUT DOWN DURING STANDBY. THE CUSTOMER COULD NOT POWER ON THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366277 ALLURA XPER FD20 IZI PHILIPS HEALTHCARE 722006

    Patients

    Seq Age Sex Outcome Treatment
    1