BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITALDIAGNOST 4.1 HIGH PERFORMANCE

    MDR report key: 21232358 · Received January 24, 2025

    Report

    Report Number
    3003768251-2025-000011
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    December 26, 2024
    Report Date
    April 17, 2025
    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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE ID: (B)(4). THIS INCIDENT IS STILL UNDER INVESTIGATION. A FINAL REPORT SHALL BE SUBMITTED AFTER COMPLETION OF INVESTIGATION.

    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 GETTING ELECTRICAL SPARK NEAR TABLE AND SMOKE IN EXAM ROOM. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO HARM TO PATIENT OR USER. THE FIELD SERVICE ENGINEER (FSE) PERFORMED ANALYSIS AND CONCLUDED THAT THE SMOKE WAS OBSERVED FROM THE SYSTEM AND FOUND THAT SMOKE COMING FROM USER APPLICATION (UA) FIELD CUSTOMER SERVICE MODULE (CSM). BASED ON THE OUTCOME OF THE INVESTIGATION OF THE DEFECTIVE PART ANALYSIS BY R&D TEAM, THE ROOT CAUSE OF THE REPORTED ISSUE WAS THE UA BOARD PROTECTION METAL OXIDE VARISTORS (MOVS) ARE DAMAGED DUE TO THE POWER FLUCTUATIONS. AND LOG FILES WERE NOT AVAILABLE FOR FURTHER INVESTIGATION. THE MOVS PROTECT THE CIRCUIT WHENEVER POWER FLUCTUATIONS OR HIGH-VOLTAGE TRANSIENTS OCCUR, SO THEY ARE DOING THEIR INTENDED WORK. DUE TO EXCESSIVE POWER SURGE THE MOVS ON THE UA BOARD WERE DAMAGED. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS DUE TO POWER FLUCTUATION IN THE HOSPITAL, THE MOVS ON THE UA FIELD CSM BOARD WERE FOUND TO BE DEFECTIVE. THE REPORTED PROBLEM WAS CONFIRMED BY THE CUSTOMER. THE DEFECTIVE PART WAS REPLACED, AND THE SYSTEM WAS SUCCESSFULLY TESTED AND CONFIRMED TO BE FUNCTIONING PROPERLY. RIS IS ACCEPTABLE AND THE ISSUE IS FURTHER TRENDED AND MONITORED. THE EVENT WAS ORIGINALLY REPORTED TO THE AUTHORITIES AS NOT ENOUGH INFORMATION WAS AVAILABLE TO MAKE A DEFINITE REPORTABILITY DECISION. SINCE THAT TIME, ADDITIONAL INFORMATION WAS RECEIVED WHICH REVEALED THAT THE EVENT DOES NOT MEET THE CRITERIA FOR REPORTING ACCORDING TO THE COUNTRY REGULATION INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE DEVICE WAS OUTSIDE OF CLINICAL USE, SPARKS WERE OBSERVED NEAR THE TABLE. THERE WAS NO PATIENT OR USER IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465930 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