BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV PULSERA 9""

    MDR report key: 2020587 · Received February 10, 2011

    Report

    Report Number
    3003768277-2011-00143
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Report Date
    January 13, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZL
    PMA / PMN Number
    K010435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION REVEALED THAT THE ENERGY STORAGE UNIT FAILED AND WAS REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING FLUOROSCOPY THE IMAGE REMAINS BLACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV PULSERA 9"" IZL (MOBILE X-RAY SYSTEM IZL PHILIPS HEALTHCARE 718091

    Patients

    Seq Age Sex Outcome Treatment
    1