BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIEHM

    MDR report key: 2715014 · Received August 21, 2012

    Report

    Report Number
    MW5026633
    Event Type
    Malfunction
    Date Received
    August 21, 2012
    Date of Event
    August 21, 2012
    Report Date
    August 21, 2012
    Manufacturer
    ZIEHM IMAGING INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, COLUMN LIFT/ LOWER BUTTON STUCK CREATING POTENTIAL FOR INJURY WHEN COLUMN CONTINUED TO DRIVE UP. UN-COMMANDED UP OR DOWN IS AN UNSAFE CONDITION. WHEN THIS OCCURRED THIS MORNING IT RESULTED IN BASE OF C-ARM LIFTING DUE TO THE TUBE "TRAPPED" UNDER THE TABLE AND COLUMN CONTINUING TO DRIVE. THIS IS AN UNSAFE CONDITION. NO ONE WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIEHM X-RAY C-ARM JAA ZIEHM IMAGING INC. VISION2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ZIEHM VISION C-ARM