BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CESAR-SCP-VISUB (V3000)

    MDR report key: 2062513 · Received March 22, 2011

    Report

    Report Number
    3003768277-2011-00258
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Report Date
    February 25, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K910370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT: "THERE WAS FIRE AND SMOKE IN THE CONTROL CABINET OF THE TECHNICAL ROOM DURING EXAMINATION". THE CONTROL CABINET EXTINGUISHED BY THE FIRE DEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CESAR-SCP-VISUB (V3000) IZI PHILIPS HEALTHCARE 72231

    Patients

    Seq Age Sex Outcome Treatment
    1