BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIEHM VISION RFD (X-RAY SYSTEM)

    MDR report key: 17661652 · Received August 30, 2023

    Report

    Report Number
    MW5145103
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Report Date
    August 29, 2023
    Manufacturer
    ZIEHM IMAGING GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ZIEHM TRACKER INTERFACE WAS DELIVERED WITH WRONG SCREW HEAD T30H INSTEAD OF T27H; THE SCREWDRIVER BIT DELIVERED WITH THE KIT HOWEVER WAS T27H. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183915 ZIEHM VISION RFD (X-RAY SYSTEM) SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA ZIEHM IMAGING GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown