BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLY C-OMCP-VISUB (H3000)

    MDR report key: 2061552 · Received March 16, 2011

    Report

    Report Number
    3003768277-2011-00257
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    February 18, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZF
    PMA / PMN Number
    K925302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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

    THE CUSTOMER STATES THAT: "THERE IS A PROBLEM IN FLUOROSCOPY, THE MACHINE STOPPED. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY C-OMCP-VISUB (H3000) IZF PHILIPS HEALTHCARE 72238

    Patients

    Seq Age Sex Outcome Treatment
    1