BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV LIBRA 9" SURVEY

    MDR report key: 2201391 · Received August 3, 2011

    Report

    Report Number
    3003768277-2011-00471
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Report Date
    July 6, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZL
    PMA / PMN Number
    K010762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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 REPORTED THAT THE SYSTEM IS TURNING OFF DURING PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV LIBRA 9" SURVEY IZL PHILIPS HEALTHCARE 718030

    Patients

    Seq Age Sex Outcome Treatment
    1