BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMBIDIAGNOST R90

    MDR report key: 23800305 · Received December 15, 2025

    Report

    Report Number
    3003768251-2025-000156
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    November 7, 2025
    Report Date
    January 12, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    MQB
    UDI-DI
    00884838101456
    PMA / PMN Number
    K141736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE ID: (B)(4). THE COMBIDIAGNOST IS A REMOTE-CONTROLLED SYSTEM, WHICH SUPPORTS GENERAL RADIOGRAPHY AND FLUOROSCOPY IMAGING. AS AN OPTION, A PORTABLE DIGITAL FLAT PANEL DETECTOR (MODEL "SKY PLATE") CAN BE USED FOR IMAGE CAPTURE. THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS FIELD SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON COMBIDIAGNOST R90 INDICATING THAT CEILING SUSPENSION HARD TO MOVE. THE FIELD SERVICE ENGINEER (FSE) PERFORMED ANALYSIS AND CONCLUDED THAT MEASURE THE FORCE THAT REQUIRES TO MOVE CEILING SUSPENSION. THE RESULTS SHOWED THAT VERTICAL MOVEMENT REQUIRES 30 N DOWNWARD AND 65 N UPWARD, LONGITUDINAL MOVEMENT REQUIRES 5 N TO THE LEFT AND 10 N TO THE RIGHT, WHILE LATERAL MOVEMENT REQUIRES 10 N FORWARD AND 9 N BACKWARD. INVESTIGATION IS IN-PROGRESS.

    Additional Manufacturer Narrative · 0

    REFERENCE ID: (B)(4). THE COMBIDIAGNOST R90 IS A REMOTE-CONTROLLED SYSTEM DESIGNED TO SUPPORT GENERAL RADIOGRAPHY AND FLUOROSCOPY IMAGING. AS AN OPTION, A PORTABLE DIGITAL FLAT PANEL DETECTOR (SKYPLATE) CAN BE USED FOR IMAGE ACQUISITION. PHILIPS RECEIVED A COMPLAINT REPORTING THAT THE CEILING SUSPENSION WAS HARD TO MOVE. DURING USE, THE OPERATOR EXPERIENCED BACK PAIN WHILE MOVING THE CEILING SUSPENSION. THE USER REQUIRED PHYSIOTHERAPY FOR TWO WEEKS AND WAS UNABLE TO RETURN TO WORK OR NORMAL ACTIVITIES FOR APPROXIMATELY THREE WEEKS. A FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND MEASURED THE FORCE REQUIRED TO MOVE THE CEILING SUSPENSION. THE MEASUREMENTS INDICATED THAT VERTICAL MOVEMENT REQUIRED 30 N DOWNWARD AND 65 N UPWARD, LONGITUDINAL MOVEMENT REQUIRED 5 N TO THE LEFT AND 10 N TO THE RIGHT, AND LATERAL MOVEMENT REQUIRED 10 N FORWARD AND 9 N BACKWARD. ALL MEASURED VALUES WERE WITHIN THE SPECIFIED LIMITS. NO SYSTEM LOG FILES WERE AVAILABLE FOR THE DATE OF THE REPORTED EVENT; THEREFORE, LOG FILE ANALYSIS COULD NOT BE PERFORMED. BASED ON RECENT IMPACT ASSESSMENTS AND REVIEW OF COMPLAINT TRENDS, PHILIPS DECIDED TO ADDRESS THIS ISSUE THROUGH A FIELD CORRECTION USING A FIELD CHANGE ORDER (FCO). THE DECISION WAS DRIVEN BY AN INCREASED NUMBER OF SIMILAR COMPLAINTS ASSOCIATED WITH SYSTEMS SUPPLIED BY A NEW SUPPLIER. THE SYSTEM WAS CONFIRMED TO BE WITHIN THE SCOPE OF THE PLANNED FCO, WHICH INCLUDES INSPECTION AND MINOR ADJUSTMENTS OF THE CEILING SUSPENSION AND IS PLANNED FOR IMPLEMENTATION AT THE SITE. THIS ISSUE DOES NOT POSE A REGULATORY COMPLIANCE RISK; HOWEVER, IN A WORST-CASE SCENARIO, PRODUCT USABILITY MAY BE AFFECTED. NEW INFORMATION INDICATED THAT USER¿S PREEXISTING BACK INJURY CONDITIONS WERE UNKNOWN. THERE WAS NO SIGNIFICANT MUSCLE OR BONE DAMAGE; IMAGING WAS NOT REQUIRED, AND THE INJURY WAS GETTING BETTER. THE USER COULD NOT RETURN TO WORK OR REGULAR ACTIVITIES FOR THREE WEEKS. PHYSICAL THERAPY SESSIONS ARE SCHEDULED FOR TWICE A WEEK. MULTIPLE ATTEMPTS WERE MADE TO CONFIRM THE EXACT SEQUENCE OF EVENTS LEADING TO THE REPORTED INJURY; HOWEVER, NO CONFIRMATION WAS RECEIVED FROM THE INJURED USER. AS A PRECAUTIONARY MEASURE AND BASED ON THE POSSIBILITY THAT VERTICAL MOVEMENT STIFFNESS COULD HAVE CONTRIBUTED TO THE INJURY, THE FSE PROCEEDED WITH PLANNING THE FCO IMPLEMENTATION TO ENSURE APPROPRIATE INSPECTION AND FOLLOW-UP. NO SIGNIFICANT MUSCLE OR BONE INJURY WAS REPORTED. THE USER¿S CONDITION IMPROVED WITH PHYSIOTHERAPY, AND RECOVERY WAS ONGOING AT THE TIME OF REPORTING. THE DEVICE WAS RESTORED TO FULL FUNCTIONALITY AND RETURNED TO CLINICAL USE. FURTHER INSPECTION AND FOLLOW-UP ACTIONS WILL BE COMPLETED AS PART OF THE PLANNED FCO IMPLEMENTATION. UPDATED EVALUATION RESULTS CODE GRID & CONCLUSION GRID CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CEILING SUSPENSION (CS) WAS DIFFICULT TO MOVE, AND AS A RESULT, THE USER EXPERIENCED A BACK INJURY. THE DEVICE WAS IN CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877544 COMBIDIAGNOST R90 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) MQB PHILIPS MEDICAL SYSTEMS DMC GMBH COMBIDIAGNOST R90 00884838101456

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention