BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZONTAL DIAGNOST H

    MDR report key: 1930391 · Received November 18, 2010

    Report

    Report Number
    3003768251-2010-00202
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COLLIMATOR LIGHT BOX WAS LOOSE AND COULD POSSIBLY FALL DOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA