BEUDAMED
    FDA Adverse Event Summary report: N

    VERTEX EPIC - GAMMA CAMERA SYSTEMS

    MDR report key: 1942933 · Received November 16, 2010

    Report

    Report Number
    2916556-2010-00021
    Date Received
    November 16, 2010
    Report Date
    October 18, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K952684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A F/U MDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEIR TABLE BROKE IN HALF CAUSING A PATIENT TO FALL OFF. THE TABLE WAS REPLACED AND RELATED SYSTEMS WERE CHECKED. THE SYSTEM WAS VERIFIED TO BE IN GOOD WORKING ORDER. THERE HAS BEEN NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX EPIC - GAMMA CAMERA SYSTEMS KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 2154-3000A

    Patients

    Seq Age Sex Outcome Treatment
    1