BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS ALLURA 15-12 (MONO)

    MDR report key: 2080133 · Received April 7, 2011

    Report

    Report Number
    3003768277-2011-00321
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Report Date
    March 9, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K002016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FROM INVESTIGATION BY ON SITE THE FIELD SERVICE ENGINEER IT WAS FOUND THAT THERE WAS A PROBLEM WITH THE VCIS SCSI PRINTED CIRCUIT BOARD AND SCSI CABLES. THIS COMPONENT CONTROLS ACCESS TO THE HARD DISK. CUSTOMER HAS REPORTED RECENT TEMPERATURE / HUMIDITY FLUCTUATIONS IN LAB ENVIRONMENT. THE REPLACEMENT OF THE DEFECTIVE PART SOLVED THE PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT "THERE IS LOSS OF ACQUISITION DURING A CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS ALLURA 15-12 (MONO) IZI PHILIPS HEALTHCARE 722043

    Patients

    Seq Age Sex Outcome Treatment
    1