BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 11610349 · Received April 2, 2021

    Report

    Report Number
    3001556265-2021-00001
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    November 2, 2020
    Report Date
    April 2, 2021
    Manufacturer
    AGFA N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER INVESTIGATION BY AGFA, IT WAS CONFIRMED THE LOG FILES FOR THIS SPECIFIC EVENT ARE NO LONGER AVAILABLE, SO THE ROOT CAUSE IS UNKNOWN. SOME POSSIBLE CAUSES INCLUDE: 1. A HARDWARE/USER ISSUE - THE DETECTOR POWER SWITCH WAS BROKEN AND THE CUSTOMER WAS USING A PEN TO TURN THE SYSTEM ON/OFF). AGFA SERVICE REPLACED THE BROKEN POWER CONNECTOR MODULE. 2. A WORKSTATION IMAGE PROCESSING FAULT. (THE LOG FILES FOR THIS SPECIFIC EVENT ARE NO LONGER AVAILABLE. 3. USER ERROR - THE USER HAS RELEASED THE EXPOSURE BUTTON TOO SOON. THERE IS NO FURTHER INVESTIGATION OR CORRECTIVE ACTIONS FOR THIS EVENT. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USER.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT. THE CUSTOMER REPORTED TO FDA VIA MEDWATCH FORM REPORT #(B)(4) THE FOLLOWING EVENT: "TECH WENT BEDSIDE TO DO PORTABLE X-RAY. EXPOSURE WAS TAKEN AND IMAGE POPPED UP BUT MACHINE WAS GIVING AN ERROR MESSAGE. ERROR: IMAGE NOT AVAILABLE. NO VALID PIXEL FILE FOUND. CONTACT YOUR SYSTEM ADMINISTRATOR. IMAGE WILL NOT SEND TO PICTURE ARCHIVE AND COMMUNICATION SYSTEM (PACS) AND IS IRRETRIEVABLE PER AGFA. THIS WAS AN AGFA EQUIPMENT ISSUE NOT A TECH ISSUE. SERVICE REPAIR TICKET WAS ENTERED AND AGFA SERVICE ENGINEER WAS CALLED TO REPAIR ISSUE. IMAGE WAS NOT RECOVERED AND PORTABLE WAS SERVICED FOR REPAIR. PATIENT WAS NOT CHARGED FOR IMAGE AND PROVIDER DID NOT NEED ADDITIONAL IMAGING FOR PATIENT. TECHNOLOGIST WAS UNABLE TO SEND PROCESSED IMAGES TO PACS DUE TO ERROR MESSAGE SAYING IMAGES NOT AVAILABLE AND NO VALID PIXEL FILE FOUND. VENDOR RESOLUTION NOTES: CLOSURE NOTES: CUSTOMER WAS UNABLE TO SEND PROCESSED IMAGES TO PAC DUE TO ERROR MESSAGE SAYING IMAGES NOT AVAILABLE NO VALID PR,<EL FILE FOUND. CAPTURE THE SNAPSHOT AND CASE IMAGES WERE UPLOADED TO FTP SERVER FOR FURTHER EVALUATION. RESTART THE UNIT COMPLETELY AND PERFORMED FLAT FILED IMAGE TEST AND SUCCESSFULLY TRANSFER TO PACS. CUSTOMER TO MARK UNIT AS DOWN UNTIL THEY REALLY GET TO THE ROOT CAUSE OF ISSUE. THE EQUIPMENT WAS REPAIRED BY AN AGFA ENGINEER. THIS IS ALL THE INFORMATION WE HAVE AVAILABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504047 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE IZL AGFA N.V. 5411/300

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO