BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV PULSERA

    MDR report key: 1884297 · Received October 25, 2010

    Report

    Report Number
    1884297
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 25, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    C-ARM FAILED TO OPERATE WHILE DOING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV PULSERA X-RAY SYSTEM, MOBILE C-ARM IZL PHILIPS MEDICAL SYSTEMS NORTH AMERICA 542055 BV PULSERA *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR