BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLY C-OMCP-VISUB (H3000)

    MDR report key: 2199674 · Received August 4, 2011

    Report

    Report Number
    3003768277-2011-00482
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Report Date
    July 6, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZF
    PMA / PMN Number
    K925302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE ENGINEER (FSE) TROUBLESHOT THE SYSTEM AND FOUND A PROBLEM THERE WAS AN INTERMITTENT ERROR IN THE COMMUNICATION BETWEEN THE GENERATOR AND THE TUBE. HE REPLACED THE PRINTED CIRCUIT BOARD (SERIAL DATA LINK) RESPONSIBLE FOR COMMUNICATION BETWEEN GENERATOR AND TUBE, THIS SOLVED THE PROBLEM. THE SYSTEM WAS LAST PRODUCED IN 1998, AND WAS DECLARED END OF LIFE AS OF 2010.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING OPERATION AN ERROR OCCURRED STATING "THAT FRONTAL GENERATOR WAS NOT AVAILABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY C-OMCP-VISUB (H3000) IZF PHILIPS HEALTHCARE 72238

    Patients

    Seq Age Sex Outcome Treatment
    1