BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUCKY DIAGNOST TH

    MDR report key: 3894159 · Received February 6, 2014

    Report

    Report Number
    3003768251-2014-00004
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Report Date
    January 10, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS GMBH DMC
    Product Code
    KPR
    PMA / PMN Number
    K945278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT FROM A CUSTOMER THAT THE OVERHEAD TUBE IS INTERMITTENTLY HARD TO MOVE. THE RADIOGRAPHER WAS NOT ABLE TO COMPLETE THE EXAM. THE RADIOGRAPHER CLAIMS TO HAVE EXPERIENCED DISCOMFORT AND PAIN IN THE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78809 BUCKY DIAGNOST TH KPR PHILIPS MEDICAL SYSTEMS GMBH DMC 70411

    Patients

    Seq Age Sex Outcome Treatment
    1