BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLY C-OMCP-VISUB (H3000)

    MDR report key: 1996134 · Received January 25, 2011

    Report

    Report Number
    3003768277-2011-00043
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Report Date
    December 27, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZF
    PMA / PMN Number
    K925302
    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 X-RAY TUBE FAILED AND WAS REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED AN ERROR INDICATING X-RAY GENERATOR IS NOT AVAILABLE.

    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