BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV25 GOLD 6"

    MDR report key: 2211942 · Received August 10, 2011

    Report

    Report Number
    3003768277-2011-00493
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Report Date
    July 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZL
    PMA / PMN Number
    K953910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 REPORTS THAT SYSTEM STOPS WORKING AFTER 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV25 GOLD 6" IZL PHILIPS HEALTHCARE 718015

    Patients

    Seq Age Sex Outcome Treatment
    1