BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIEHM VISION RFD 3D C-ARM

    MDR report key: 17699560 · Received September 6, 2023

    Report

    Report Number
    MW5145287
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Report Date
    September 5, 2023
    Manufacturer
    ZIEHM IMAGING GMBH
    Product Code
    OWB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING SURGERY, SURGEON COMPLAINT ABOUT ZIEHM C-ARM AND NAV (NAVIGATION) ACCURACY. AFTER PERFORMING A CALIBRATION VERIFICATION WITH THE CALIBRATION PEGBOARD, IT HAS BEEN CONFIRMED THE AVERAGE ERROR VALUE WAS ABOVE THE LIMITS. ZIEHM NAVIGATION NOT ACCURATE. ZIEHM TECHNICIAN NOT AVAILABLE, SO CALIBRATION HAD TO BE POSTPONED. REFERENCE REPORT: MW5145288. 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
    826794 ZIEHM VISION RFD 3D C-ARM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB ZIEHM IMAGING GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown