BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITALDIAGNOST C90 HIGHPERFORMANCE

    MDR report key: 22169268 · Received June 9, 2025

    Report

    Report Number
    3003768251-2025-000081
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 8, 2025
    Report Date
    July 28, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    MQB
    UDI-DI
    00884838090699
    PMA / PMN Number
    K182973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    REFERENCE ID: (B)(6). THE DIGITALDIAGNOST C90 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 C90 INDICATING THAT BURNED BOARD UA FIELD. THE USE OF DEVICE WAS UNKNOWN THERE WAS NO HARM TO PATIENT OR USER. THE FIELD SERVICE ENGINEER (FSE) PERFORMED AN ONSITE INSPECTION AND CONCLUDED THAT THE MAIN CIRCUIT BREAKER (MCB) LOCATED WITHIN THE WALL-MOUNTED POWER DISTRIBUTION PANEL (PDP) WAS BURNT AND SEVERELY DAMAGED, LIKELY DUE TO SEVERE OR REPEATED POWER SURGES OR FLUCTUATIONS. THESE POWER ANOMALIES RESULTED IN A SHORT CIRCUIT (SC) WITHIN THE PDP, WHICH LED TO THE FAILURE AND BURNOUT OF THE MCB, AND SUBSEQUENTLY CAUSED CATASTROPHIC DAMAGE TO THE UA PCB SURGE PROTECTION COMPONENT, SPECIFICALLY THE METAL OXIDE VARISTOR (MOV). ALTHOUGH NO ACTIVE FLAMES OR VISIBLE SMOKE WERE OBSERVED DURING THE FSE¿S INSPECTION, IT WAS LATER CLARIFIED THAT THIS WAS DUE TO THE DEFECTIVE WALL-MOUNTED MCB HAVING ALREADY BEEN REPLACED BY THE VENDOR WITH THE SUPPORT OF THE PROJECT TEAM, PRIOR TO THE FSE'S ARRIVAL. THE CUSTOMER REPORTED SPARKING AND VISIBLE FLAME HAD OCCURRED EARLIER, WHICH ALIGNS WITH THE CONDITION OF THE BURNED COMPONENTS AND SUPPORTS THE CONCLUSION OF AN ELECTRICAL EVENT. FURTHERMORE, EVEN AFTER THE MCB REPLACEMENT, THE FSE OBSERVED SPARKING AND VISIBLE FLAMES WHEN ATTEMPTING TO POWER ON THE SYSTEM¿THIS WAS TRACED TO THE DAMAGED MOV ON THE UA PCB, WHICH WAS STILL SHORTED. THE ELECTRICAL ARCING PERSISTED UNTIL THE DEFECTIVE UA PCB WAS REPLACED. THIS CONFIRMS THAT THE MOV FAILURE CONTRIBUTED TO ADDITIONAL INTERNAL DAMAGE AND WAS A CRITICAL POINT OF FAILURE. THE CORRECTIVE ACTIONS INCLUDED REPLACEMENT OF: THE UA FIELD CSM BOARD FIELD REPLACEABLE UNIT (FRU), POWER SUPPLIES (12V AND 24V DC), AND CONNECTING CABLES. ALL DAMAGED COMPONENTS WERE ISOLATED TO PREVENT FURTHER ELECTRICAL RISK. AFTER REPLACEMENT AND FULL FUNCTIONAL TESTING, THE SYSTEM WAS SUCCESSFULLY POWERED ON AND RETURNED TO CLINICAL USE UNDER CLOSE OBSERVATION. TECHNICAL INVESTIGATION OUTCOME (R&D TEAM): THE RESEARCH AND DEVELOPMENT (R&D) TEAM ANALYZED THE INCIDENT BASED ON THE IMAGES AND DETAILS PROVIDED BY THE FIELD SERVICE ENGINEER (FSE) AND CONCLUDED THAT THE WALL-MOUNTED PDP IS NOT PART OF THE PHILIPS SYSTEM. THE DAMAGE IS LIKELY ATTRIBUTED TO EITHER A SHORT CIRCUIT (DIRECT CONNECTION BETWEEN LIVE AND NEUTRAL LEADING TO CURRENT SURGE AND INTERNAL ARCING) OR A HIGH-VOLTAGE SURGE (POSSIBLY DUE TO LIGHTNING, GRID SWITCHING, OR FAULTY INFRASTRUCTURE). BASED ON THE COMPREHENSIVE INFORMATION RECEIVED, DEFECTIVE PART RETURN AND ANALYSIS ARE NOT REQUIRED, AS THE R&D TEAM CONFIRMED THAT SUFFICIENT EVIDENCE WAS AVAILABLE TO COMPLETE THE TECHNICAL INVESTIGATION. THE MOV ON THE UA PCB¿WHICH FUNCTIONS AS A SURGE PROTECTION COMPONENT¿WAS FOUND TO HAVE DEGRADED DUE TO PROLONGED EXPOSURE TO ELECTRICAL SURGES. THIS DEGRADATION ULTIMATELY LED TO MOV FAILURE, CAUSING ADDITIONAL DAMAGE TO NEARBY COMPONENTS ON THE BOARD. LOG FILE ANALYSIS OUTCOME: THE SYSTEM LOG FILES WERE REVIEWED, REVEALING ONLY HARD SHUTDOWN ERRORS RELATED TO THE INCIDENT. OTHER UNRELATED ERRORS WERE PRESENT BUT NOT ASSOCIATED WITH THE POWER FAILURE. BASED ON AVAILABLE INFORMATION, FIELD FEEDBACK, AND TECHNICAL ANALYSIS, THE CAUSE OF THE REPORTED ISSUE WAS A POWER SURGE LED TO SHORT CIRCUIT WITHIN THE WALL-MOUNTED POWER DISTRIBUTION PANEL, WHICH TRIGGERED THE FAILURE AND BURNOUT OF THE MCB AND SUBSEQUENTLY THE MOV ON THE UA PCB, RESULTING IN VISIBLE SPARKING AND FLAME. WHILE NO PATIENT OR USER HARM OCCURRED, THE ISSUE WAS CONFIRMED BY THE CUSTOMER AND HAS BEEN RESOLVED THROUGH COMPONENT REPLACEMENT. THE SYSTEM IS NOW FUNCTIONING WITHIN SPECIFICATIONS. CONCLUSION: UPDATED EVALUATION METHOD CODE. UPDATED EVALUATION RESULTS CODE. UPDATED (DEVICE) PROBLEM CODE GRID. UPDATED CONCLUSION CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UA BOARD WAS BURNT. THE USAGE OF THE DEVICE AT THE TIME OF THE INCIDENT IS UNKNOWN AND THERE WAS NO PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320306 DIGITALDIAGNOST C90 HIGHPERFORMANCE SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) MQB PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST C90 00884838090699

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown