BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITALDIAGNOST C90 HIGHPERFORMANCE

    MDR report key: 19554414 · Received June 17, 2024

    Report

    Report Number
    3003768251-2024-00035
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    March 26, 2024
    Report Date
    October 23, 2024
    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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE ID: (B)(4). 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 FIELD SERVICE ENGINEER INVESTIGATED ON SITE AND CHECKED THE DETECTOR CONFIRMING THAT THE DETECTOR WAS DROPPED MULTIPLE TIMES. THE DETECTOR WAS CALIBRATED AND RETURNED FOR USE.

    Additional Manufacturer Narrative · 0

    REFERENCE ID: (B)(4). COMBINED (INITIAL & FINAL) EMDR REPORT WAS SUBMITTED ON TIME WITH EMDR REPORT NUMBER (B)(4). A DUPLICATE REPORT WAS INADVERTENTLY SUBMITTED WITH EMDR REPORT NUMBER 3003768251-2024-00072 (5241166). IT IS A REQUEST TO IGNORE THE DUPLICATE REPORT SUBMITTED. FOLLOWING ARE THE CORRECTIONS MADE PERTAINING TO EMDR REPORT NUMBER (B)(4): 1. CONTACT OFFICE: CHANGED FROM "JOHN MAGA" TO "DUSTY LEPPERT" 2. DATE RECEIVED BY MFG: CHANGED FROM "BLANK" TO "3/26/2024".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DETECTOR WAS NOT CONNECTING TO THE SYSTEM. THERE WAS NO PATIENT OR USER IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009196 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