BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSENTA DR COMPACT

    MDR report key: 21123185 · Received January 10, 2025

    Report

    Report Number
    3003768251-2025-000007
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    December 12, 2024
    Report Date
    April 17, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    MQB
    PMA / PMN Number
    K070528
    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). THE ESSENTA DR COMPACT IS A DIGITAL RADIOGRAPHY SYSTEM THAT'S DESIGNED TO FIT SMALL ROOMS. PHILIPS RECEIVED A COMPLAINT ON ESSENTA DR COMPACT INDICATING THAT THE EXPOSURE NOT HAPPENING AND SMOKE COMING FROM THE SYSTEM. THE DEVICE WAS NOT IN CLINICAL USE AND THERE WAS NO HARM TO PATIENT OR USER. THE FIELD SERVICE ENGINEER (FSE) PERFORMED ANALYSIS AND CONCLUDED THAT THE CUSTOMER OBSERVED SMOKE FROM THE SYSTEM. FSE CHECKED THE SYSTEM AND FOUND THAT COMPONENTS ON THE ROTOR CONTROLLER PCB HAD BURNT OUT. BASED ON THE TECHNICAL INVESTIGATION OF THE DEFECTIVE PART ANALYSIS BY R&D TEAM, THE MOVS (METAL OXIDE VARISTORS) ON THE ROTOR CONTROLLER BOARD LOCATED IN THE M-CABINET WERE FOUND TO BE BURNT. THE VARISTORS WILL PREVENT THE POWER SURGE TO AVOID THE PART DAMAGE DUE TO HIGH POWER SUPPLY. MOVS ARE PROTECTIVE COMPONENTS DESIGNED TO GUARD SENSITIVE CIRCUITRY FROM POWER SURGES BY CLAMPING HIGH VOLTAGE LEVELS AND DIVERTING EXCESS ENERGY. ROOT CAUSE: THE DAMAGE TO THE MOVS WAS CAUSED BY AN EXCESSIVE POWER SURGE. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS DUE TO POWER SURGE IN THE HOSPITAL, THE MOVS ON THE ROTOR CONTROLLER BOARD IN THE M-CABINET WERE FOUND TO BE BURNT. THE REPORTED PROBLEM WAS CONFIRMED BY THE CUSTOMER. THE DEFECTIVE ROTOR CONTROLLER WAS REPLACED, AND FOLLOWING THE CORRECTIVE MAINTENANCE, THE SYSTEM WAS SUCCESSFULLY TESTED AND CONFIRMED TO BE FUNCTIONING PROPERLY. RISK 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.

    Additional Manufacturer Narrative · 0

    REFERENCE ID: (B)(4). THE ESSENTA DR COMPACT IS A DIGITAL RADIOGRAPHY SYSTEM THAT'S DESIGNED TO FIT SMALL ROOMS. PHILIPS RECEIVED A COMPLAINT ON ESSENTA DR COMPACT INDICATING THAT THE EXPOSURE NOT HAPPENING AND SMOKE COMING FROM THE SYSTEM. THE DEVICE WAS NOT IN CLINICAL USE AND THERE WAS NO HARM TO PATIENT OR USER. THE FIELD SERVICE ENGINEER (FSE) PERFORMED ANALYSIS AND CONCLUDED THAT THE CUSTOMER OBSERVED SMOKE FROM THE SYSTEM. FSE CHECKED THE SYSTEM AND FOUND THAT COMPONENTS ON THE ROTOR CONTROLLER PCB HAD BURNED OUT. THE DEFECTIVE ROTOR CONTROLLER WAS REPLACED, AND FOLLOWING THE CORRECTIVE MAINTENANCE, THE SYSTEM WAS SUCCESSFULLY TESTED AND CONFIRMED TO BE FUNCTIONING PROPERLY. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS ROTOR CONTROLLER PCB DEFECTIVE. THE REPORTED PROBLEM WAS CONFIRMED BY THE CUSTOMER. THE ROOT CAUSE OF THE PART MALFUNCTION IS STILL UNKNOWN AND IS UNDER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXPOSURE NOT HAPPENING AND SMOKE COMING FROM THE SYSTEM. THE DEVICE WAS NOT IN CLINICAL USE AND THERE WAS NO HARM TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366069 ESSENTA DR COMPACT SYSTEM, X-RAY, STATIONARY MQB PHILIPS MEDICAL SYSTEMS DMC GMBH ESSENTA DR COMPACT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown