BEUDAMED
    FDA Adverse Event Other Summary report: N

    HORIZONTALDIAGNOST H

    MDR report key: 1914366 · Received November 18, 2010

    Report

    Report Number
    3003768251-2010-00204
    Event Type
    Other
    Date Received
    November 18, 2010
    Date of Event
    March 11, 2008
    Report Date
    March 11, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM IS APPROX 30 YEARS OLD AND THE COLLIMATOR LAMP TIMER BOARD WAS REDESIGNED DUE TO COMPONENT OBSOLESCENCE. THE SYSTEM HAD BEEN UPDATED WITH THE NEW TIMER BOARD AND THE CUSTOMER FELT IT WAS TOO LONG AND THE LAMP COVER COULD GET TOO HOT. HOWEVER, THE FIXED SETTING OF 45 SECONDS IS PER PRODUCT SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THE COVER ON THE COLLIMATOR LAMP GOT TOO HOT WITH A FIXED LAMP TIMER SETTING OF 45 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZONTALDIAGNOST H IXR (RADIOGRAPHIC TABLE) IXR PHILIPS MEDICAL SYSTEMS DMC GMBH 70404 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA