BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITALDIAGNOST 4 HIGH PERFORMANCE

    MDR report key: 21643897 · Received March 19, 2025

    Report

    Report Number
    3003768251-2025-000034
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    February 18, 2025
    Report Date
    March 19, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    MQB
    PMA / PMN Number
    K141736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE ID: (B)(4). THE DIGITALDIAGNOST 4.X IS A STATIONARY X-RAY SYSTEM FOR GENERAL RADIOGRAPHIC PURPOSES. AS AN OPTION, A PORTABLE DIGITAL FLAT PANEL DETECTOR (MODEL "SKYPLATE") CAN BE USED FOR IMAGE CAPTURE. PHILIPS RECEIVED A COMPLAINT ON DIGITALDIAGNOST 4.X INDICATING THAT AN ABNORMAL IMAGE OCCURRED ON THE SKYPLATE MINI. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO HARM TO PATIENT OR USER. THE REMOTE SERVICE ENGINEER (RSE) PERFORMED ANALYSIS AND CONCLUDED THAT THE DETECTOR WAS DROPPED BY THE CUSTOMER, CAUSING AN IMAGE ABNORMALITY. INITIALLY, ONLY THE OUTLINE SHOWED IN GRAY ON A BLACK SCREEN. THE ISSUE DID NOT RECUR AFTER REMOVING AND REINSERTING THE SKYPLATE'S BATTERIES. THE REMOTE LOG ANALYSIS SHOWED INTERNAL OPERATION ABNORMALITY IN THE PORTABLE DETECTOR, ALONG WITH A DECREASE IN WI-FI SIGNAL STRENGTH, BUT NO OTHER MAJOR PROBLEMS WERE FOUND. AFTER CONSULTATION, CUSTOMER WAS DECIDED TO CONTINUE USING THE DEVICE AS IS, AND DEVICE WAS RETURNED TO USE. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS DETECTOR DROP. THE REPORTED PROBLEM WAS CONFIRMED BY THE CUSTOMER. THUS, IT IS CONCLUDED THAT THE DETECTOR WAS DROPPED BY ACCIDENT (USE ERROR).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ABNORMAL IMAGE OCCURRED DUE TO DETECTOR DROP. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640420 DIGITALDIAGNOST 4 HIGH PERFORMANCE SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) MQB PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST 4 HIGH PERFORMANCE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown