BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV PULSERA REL 2

    MDR report key: 1221763 · Received July 18, 2008

    Report

    Report Number
    1217116-2008-00056
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 23, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BASED ON TREND ANALYSIS OF COMPLAINTS, IT WAS DETERMINED THIS MOBILE X-RAY, WITH EXTENDED ROTATION OPTION, C-ARC ASSEMBLY BRAKING MECHANISM / ROTATIONAL LOCK WILL RANDOMLY NOT HOLD THE ARM IN REQUESTED POSITION FOR EXTENDED ROTATION IF AN EXTERNAL FORCE IS APPLIED BY THE MEDICAL STAFF. THE C-ARM WILL MOVE ON ITS OWN. IF THE C-ARM IS "PUSHED" BY MEDICAL STAFF THERE IS POTENTIAL OF PT INJURY IF A NEUROLOGICAL OR VESSEL CATHETERIZATION PROCEDURE ARE BEING PERFORMED. THERE HAVE BEEN NO REPORTED INJURIES OR MDRS DUE TO THIS C-ARM MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV PULSERA REL 2 IZL (MOBILE X-RAY SYSTEM) IZI PHILIPS MEDICAL SYSTEMS 718094 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *