BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CESAR/C-STANDFLOOR-OMCP-VISUB-CCD (V5000)

    MDR report key: 2061555 · Received March 16, 2011

    Report

    Report Number
    3003768277-2011-00287
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    February 21, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K984545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE VIEWING SUB SYSTEM (VISUB) WOULDN'T BOOT UP. UNABLE TO GET VIEWING SYSTEM STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CESAR/C-STANDFLOOR-OMCP-VISUB-CCD (V5000) IZI PHILIPS HEALTHCARE 72248

    Patients

    Seq Age Sex Outcome Treatment
    1