BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITALDIAGNOST 3.1.X

    MDR report key: 16589923 · Received March 22, 2023

    Report

    Report Number
    3003768251-2023-00010
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    MQB
    PMA / PMN Number
    K131483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REF. ID: 3082157 THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 0

    REF. ID: (B)(4). THE DIGITALDIAGNOST IS A STATIONARY X-RAY SYSTEM FOR GENERAL RADIOGRAPHIC PURPOSES. AS AN OPTION, A PORTABLE DIGITAL FLAT PANEL DETECTOR (MODEL "WPD") CAN BE USED FOR IMAGE CAPTURE. THE LOCAL FIELD SERVICE ENGINEER (FSE) WENT ON SITE, CHECKED THE DETECTOR AND TRIED SEVERAL TIMES TO CONNECT THE DETECTOR WITH NO SUCCESS. HE INITIATED THE REPLACEMENT OF THE DETECTOR. THE NEW DETECTOR WAS INSTALLED. FINALLY, THE SYSTEM MEETS THE SPECIFICATION FOR THE PERFORMED SERVICE AND IS RETURNED TO USE. 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). RISK ESTIMATION REVEALED ACCEPTABLE RISK PER RISK BENEFIT ANALYSIS, BECAUSE ACTUALLY, THERE IS NO FEASIBLE TECHNICAL SOLUTION FOR THIS KIND OF ¿USE ERROR¿. THIS ISSUE IS FURTHER MONITORED AND TRENDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PORTABLE DETECTOR NOT CONNECTING TO THE SYSTEM. ISSUE STARTED AFTER THE DETECTOR BEING DROPPED. A DROPPED DETECTOR CAN LEAD IN WORST CASE TO A FRACTURE IN THE FOOT. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437720 DIGITALDIAGNOST 3.1.X SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) MQB PHILIPS MEDICAL SYSTEMS DMC GMBH 712026

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown