BEUDAMED
    FDA Adverse Event Death Summary report: N

    POLY C-OMCP-VISUB (H3000)

    MDR report key: 2093545 · Received May 11, 2011

    Report

    Report Number
    3003768277-2011-00346
    Event Type
    Death
    Date Received
    May 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    PHILPS HEALTHCARE
    Product Code
    IZL
    PMA / PMN Number
    K925302
    Adverse Event
    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

    POSSIBLE EQUIPMENT FAILURE MAY HAVE CAUSED A PT'S DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1