BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITALDIAGNOST 4.1 HIGH PERFORMANCE

    MDR report key: 19946887 · Received August 9, 2024

    Report

    Report Number
    3003768251-2024-00053
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 16, 2024
    Report Date
    November 11, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    MQB
    UDI-DI
    00884838065321
    PMA / PMN Number
    K141736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REF ID: 4971848 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 AN AUTOMATIC COMPLAINT ON THE DIGITALDIAGNOST 4.1 HIGH PERFORMANCE INDICATING THAT ¿REMOTE ALERT: DXR.DET.DET.HEAVYSHOCK_ALERT V2.9¿. NO HARM WAS REPORTED. THE LOCAL REMOTE SERVICE ENGINEER (RSE) SENT OUT AN EMAIL TO THE CUSTOMER, ASKING ABOUT THE DETECTOR STATUS. CUSTOMER HAS NOT NOTICED AN IMAGING OR PHYSICAL PROBLEM. INVESTIGATION REVEALED THAT THE CUSTOMER HAD DROPPED THE DETECTOR, BUT IT WAS STILL WORKING PROPERLY. SYSTEM IS FULLY FUNCTIONAL. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS THE DETECTOR DROP. THE REPORTED PROBLEM WAS CONFIRMED. NO DETAILS WERE PROVIDED ABOUT THE CIRCUMSTANCES WHEN THE DETECTOR FELL DOWN. AS THE CUSTOMER DID NOT MAKE OTHER CLAIMS, IT IS CONCLUDED THAT THE DETECTOR WAS DROPPED BY ACCIDENT (USE ERROR). THE DEVICE WAS OPERATIONAL AS INTENDED AND CUSTOMER STATED THAT THERE WAS NO PHYSICAL DAMAGE AND NO IMAGING ISSUE.

    Additional Manufacturer Narrative · 0

    REFERENCE ID: 5043092. FOLLOWING ARE THE CORRECTIONS MADE PERTAINING TO EMDR REPORT NUMBER 3003768251-2024-00053 (5043092): 1. CONTACT OFFICE: CHANGED FROM (B)(6). 2. REPORT SOURCE - CHANGED FROM "COMPANY REPRESENTATIVE, FOREIGN, HEALTH PROFESSIONAL, USER FACILITY," TO "COMPANY REPRESENTATIVE, FOREIGN, HEALTH PROFESSIONAL".

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ALLEGING THAT ¿A REMOTE ALERT FOR THE DETECTOR RECEIVING HEAVY SHOCKS WAS RECORDED¿. ADDITIONAL INFORMATION RECEIVED FROM THE PHILIPS REMOTE SERVICE PERSONNEL CONFIRMING FROM THE CUSTOMER THAT THE HEAVY SHOCK ALERT WAS DUE TO DETECTOR BEING DROPPED ACCIDENTALLY. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561650 DIGITALDIAGNOST 4.1 HIGH PERFORMANCE SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) MQB PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST 4.1 HIGH PERFORMANCE 00884838065321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown