BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 4203444 · Received October 27, 2014

    Report

    Report Number
    9616389-2014-00029
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    January 15, 2015
    Report Date
    February 2, 2015
    Manufacturer
    AGFA HEALTHCARE N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: RELATED TO NEW ARRESTOR TO PREVENT ELECTROSTATIC DISCHARGE.

    Description of Event or Problem · 1

    THIS MEDIAL DEVICE REPORT IS BEING SUBMITTED DUE TO AN ADDITIONAL SAME ISSUE THAT WAS ORIGINALLY REPORTED IN MDR REPORT, FDA # 9616389-2013-00003. THIS REPORT IS FOR A 23RD EVENT FOR THE UNINTENDED MOVEMENT ISSUE WHEN USING A DX-D100 MOBILE UNIT. THE CUSTOMER INFORMED AGFA SERVICE ON OCTOBER 2, 2014, THAT THE DX-D100 PORTABLE UNIT WAS BEING DRIVEN OFF THE ELEVATOR WHEN IT UNEXPECTEDLY ACCELERATED. THE TECHNOLOGIST STATED THAT SHE LET GO OF THE UNIT HANDLE AND THE UNIT MOVED OFF TOWARD THE RIGHT AND RAN INTO A WALL. AGFA SERVICE REQUESTED THE SITE TO ISOLATE THE DX-D100 UNIT AND NOT USE UNTIL IT COULD BE INSPECTED. HOWEVER, WHEN THE AGFA SERVICE ENGINEER ARRIVED AT THE SITE THE FOLLOWING MORNING, THE DX-D100 UNIT WAS IN USE AND THE TECHNOLOGIST STATED SHE HAD BEEN USING IT ALL NIGHT AND HAD NO PROBLEMS WITH THE UNIT. A MANDATORY UPGRADE PER MANDATORY SERVICE BULLETIN (MSB) DIS078.14E HAD ALREADY BEEN PERFORMED PRIOR TO THIS EVENT, IN WHICH THE FIRMWARE V11R3B4 AND A REQUIRED ISOLATION KIT HAD BEEN INSTALLED. THE AGFA SERVICE ENGINEER INSPECTED THE DIGITAL MOTION CONTROL (DMC) BOARD AND CONFIRMED DMC BOARD REV H WITH FIRMWARE V11R3B4 WAS INSTALLED. ADDITIONAL CHECKS OF THE CONNECTIONS AND BOARDS FOR SIGNS OF WEAR, CRACKS OR OTHER VISUAL DEFECTS WERE PERFORMED AND NO ISSUES WERE IDENTIFIED. CONFIRMATION THE GAUGE VOLTAGE WAS SET CORRECTLY WAS ALSO DONE. THE AGFA SERVICE ENGINEER DROVE THE UNIT THROUGH THE HOSPITAL FOR NEARLY 45 MINUTES WITH THE TECHNOLOGIST WHO EXPERIENCED THE ISSUE. AGFA WAS UNABLE TO FIND ANY ISSUES OR EXPERIENCE UNEXPECTED BEHAVIOR WHILE USING THE DX-D100 UNIT. THE AGFA SERVICE ENGINEER CHECKED AND ADJUSTED THE CHAIN TENSION ON THE UNIT AND ALSO DECIDED TO REPLACE THE DMC BOARD. AS OF (B)(4), 2014, THE DX-D100 UNIT HAS BEEN BACK IN SERVICE AT THE CUSTOMER SITE AND NO FURTHER PROBLEMS HAVE BEEN REPORTED. AGFA WILL CONTINUE TO WORK WITH SEDECAL AS THE TECHNICAL ASPECT OF THIS COMPLAINT WILL BE INVESTIGATED FURTHER. UNINTENDED MOVEMENT OF DX-D100S HAS ALREADY BEEN COMMUNICATED FOR A REPORTABLE CORRECTION TO THE FDA: (B)(4). NO PATIENT OR USER WAS INJURED DURING THIS EVENT.

    Description of Event or Problem · 1

    (B)(4), AGFA'S SUPPLIER, VISITED THE SITE DOCUMENTED IN THIS MEDICAL DEVICE REPORT AND FURTHER INVESTIGATED THE ISSUES RELATED TO AND REPORTED AS UNINTENDED MOVEMENT OF THE DX-D100. (B)(4) PERFORMED SEVERAL ELECTROSTATIC TESTS. ONE TEST WAS TO EMULATE A USER WHO HAS STORED AN ELECTROSTATIC ENERGY IN HIS OR HER BODY TO DETERMINE IF THE STORED ENERGY IS DISCHARGED THROUGH TO THE GROUNDED EQUIPMENT AND POSSIBLY AFFECTING THE NORMAL OPERATION OF THE EQUIPMENT. (B)(4) PROCEEDED TO TEST THE COMPATIBILITY OF SEVERAL TYPES OF FLOORING WITHIN THE HOSPITAL ENVIRONMENT. (B)(4) DISCOVERED AND CONFIRMED THE CAUSE FOR THE UNINTENDED MOVEMENT INITIALLY REPORTED FOR THIS EVENT WAS DIFFERENT FROM PREVIOUSLY REPORTED UNINTENDED MOVEMENT. THE MOBILE UNIT ITSELF WAS ACTUALLY BUILDING UP STORED ENERGY AND GETTING CHARGED. ON (B)(6) 2015, (B)(4) REPORTED TO AGFA THE CAUSE WAS INDEED DIFFERENT. IT IS RELATED TO AN ELECTROSTATIC DISCHARGE WHEN DRIVING OVER METAL THRESHOLDS OR WHILE ENTERING/LEAVING AN ELEVATOR. (B)(4) WILL BE IMPLEMENTING A CORRECTIVE ACTION RELATED TO A NEW ARRESTOR. CORRECTIVE ACTIONS FOR THIS SITE ISSUE WILL BE DOCUMENTED VIA PROBLEM RECORD, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682410 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE WIRELESS IZL AGFA HEALTHCARE N.V. DX-D100 MOBILE WIRELESS DR

    Patients

    Seq Age Sex Outcome Treatment
    1