BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV LIBRA 9" SURVEY

    MDR report key: 2061553 · Received March 16, 2011

    Report

    Report Number
    3003768277-2011-00256
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    February 18, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZL
    PMA / PMN Number
    K010762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE ENGINEER TROUBLESHOOT THE SYSTEM AND FOUND THAT THE POWER DISTRIBUTION UNIT WAS NOT SUPPLYING POWER. HE REPLACED THE "PART NUMBER (B)(4) - ASSY POWER SUPPLY", WHICH SOLVED THE PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT: "THE STAND SHUTS OFF ONCE IN A WHILE".

    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