BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALKSTATION

    MDR report key: 7303666 · Received February 28, 2018

    Report

    Report Number
    9616389-2018-00003
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    December 14, 2017
    Report Date
    February 28, 2018
    Manufacturer
    AGFA HEALTHCARE N.V.
    Product Code
    OUG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDEED STANDARD AND RECOMMENDED PRACTICE THAT RADIOLOGISTS REVIEW AND - IF NECESSARY - CORRECT REPORTS BEFORE SIGN-OFF. THIS IS THE COMPLETE REPORT FROM THE CUSTOMER: "FOLLOWING IS MY REPORT ON THE SUBJECT PATIENT: INDICATION: REASON FOR STUDY ON IMPAX "BILATERAL LEG PAIN WITH WEIGHTBEARING" RIGHT LOWER EXTREMITY: THE COMMON FEMORAL VEIN, PROXIMAL SFV/PROFUNDA, AND PROXIMAL/MID FEMORAL VEIN ARE COMPRESSIBLE, ALSO COMPRESSIBILITY OF THE POPLITEAL VEIN. POOR VISUALIZATION OF THE DISTAL FEMORAL VEIN ON GRAYSCALE IMAGING WITH AND WITHOUT COMPRESSION. INCOMPLETE SONOGRAPHIC VISUALIZATION OF THE GREATER SAPHENOUS VEIN, ALTHOUGH THERE IS CONTINUOUS MILDLY PHASIC VENOUS WAVE FORM IN THE UPPER PORTION OF THE GREATER SAPHENOUS VEIN ON COMBINED COLOR/PULSE DOPPLER IMAGING. PATENCY OF THE RIGHT FEMORAL AND POPLITEAL VEIN. LEFT LOWER EXTREMITY: COMPRESSIBILITY OF THE COMMON FEMORAL VEIN AND SAPHENOFEMORAL CONFLUENCE, SUPERFICIAL FEMORAL VEIN, AND POPLITEAL VEIN. SUBOPTIMAL ULTRASOUND IMAGING OF CALF VEINS BILATERALLY. IMPRESSION: NO OBJECTIVE EVIDENCE OF LEFT LOWER EXTREMITY ACUTE DVT BETWEEN THE LEVEL OF THE COMMON FEMORAL VEIN AND POPLITEAL VEIN OBJECTIVE EVIDENCE OF RIGHT LOWER EXTREMITY ACUTE DVT EXCEPT POOR VISUALIZATION OF THE DISTAL SUPERFICIAL FEMORAL VEIN WITH AND WITHOUT COMPRESSION ALTHOUGH THERE IS INTRALUMINAL FLOW; NONOCCLUSIVE DVT IN THIS SEGMENT OF THE FEMORAL VEIN IS NOT ENTIRELY RULED OUT. PLEASE SEE ABOVE COMMENTS. CODE 4 ASSIGNED TO THIS DICTATION WHICH TRIGGERS AN AUTOMATIC VISTA E-MAIL ALERT TO THE REQUESTING HEALTH CARE PROVIDER. *ADDENDUM* TYPOGRAPHICAL MISTAKE IN THE CONCLUSION OF THE REPORT AS FOLLOWS: "OBJECTIVE EVIDENCE" SHOULD BE "NO OBJECTIVE EVIDENCE" CORRECTION DISCUSSED DIRECTLY WITH INPATIENT INTERN PROVIDER (B)(6) M.D. ON (B)(6) 2017 AT 0805.

    Description of Event or Problem · 1

    ON (B)(6) 2018, A CUSTOMER REPORTED TO AGFA THAT WHILE USING THE AGFA TALKSTATION, THE FIRST WORD OF A DICTATED SENTENCE WAS OMITTED IN A SPECIFIC REPORT AND THAT THERE WERE LOTS OF ISSUES WITH THE PATIENT AFTERWARDS AS A RESULT OF TREATMENT BASED ON THE REPORT. BASED ON THIS INFORMATION, AGFA STARTED REQUESTING FURTHER DETAILS. ON 29 JANUARY, THE PATIENT SAFETY MANAGER AT THE SITE RESPONDED, "THE PATIENT RECEIVED UNNECESSARY MEDICAL TREATMENT AND HARM AS A RESULT." THE REPORT SENTENCE THAT MISSED AN INITIAL "NO", WAS ALSO COMMUNICATED: "OBJECTIVE EVIDENCE OF RIGHT LOWER EXTREMITY ACUTE DVT EXCEPT POOR VISUALIZATION OF THE DISTAL SUPERFICIAL FEMORAL VEIN WITH AND WITHOUT COMPRESSION ALTHOUGH THERE IS INTRALUMINAL FLOW; NON OCCLUSIVE DVT IN THIS SEGMENT OF THE FEMORAL VEIN IS NOT ENTIRELY RULED OUT." DVT = DEEP VEIN THROMBOSIS WE REQUESTED FURTHER DETAILS ON THE UNNECESSARY TREATMENT AND PATIENT HARM. ON 13 FEBRUARY, THE PATIENT SAFETY MANAGER AT THE SITE RESPONDED, "THE PATIENT WAS TREATED WITH ANTICOAGULANTS BASED ON A DIAGNOSIS OF DVT TO THE RLE. THE PATIENT ENDED UP HAVING AN ABDOMINAL WALL BLEED FROM THE ANTICOAGS AND NEEDED SURGICAL INTERVENTION. THE PATIENT DID NOT HAVE A DVT. THE WORD "NO" WAS OMITTED BY THE DICTATION SYSTEM ON TRANSCRIPTION. "RLE = RIGHT LOWER EXTREMITIES "ON TRANSCRIPTION" = WHEN IT WAS BEING TRANSCRIBED BY THE DICTATION SYSTEM. BASED ON THIS RESPONSE, AGFA'S MEDICAL EXPERT CONFIRMED THE RISK RATING FOR THIS EVENT AND PROCEEDED TO REQUEST FURTHER INFORMATION. TALKSTATION IS A FLEXIBLE DICTATION INTERFACE ALLOWING FOR REAL TIME OR BATCH MODE DICTATION. MACROS AND TEMPLATES, QUICK CODING (SPEECH AND KEYBOARD COMMANDS) AND PACS/RIS INTEGRATION STREAMLINE THE DICTATION PROCESS. IT MINIMIZES THE RADIOLOGISTS' TIME AND EFFORT REQUIRED TO COMPLETE THE DAILY REPORTING ACTIVITIES. TALKSTATION REPLACES TRADITIONAL BACK-END ANALOG DICTATE/TRANSCRIBE METHODOLOGIES, WITH FRONT-END SPEECH RECOGNITION TECHNOLOGY, PROVIDING ACCURATE AND PRODUCTIVE REPORTING. TALKSTATION IS AVAILABLE AS A FULLY INTEGRATED APPLICATION WITHIN AGFA'S HEALTHCARE SUITES. IN ADDITION, IT IS DEPLOYED AS A STANDALONE PRODUCT AND CAN BE EASILY INTEGRATED INTO A HEALTHCARE INFRASTRUCTURE. IN OCTOBER 2016, TALKSTATION WAS CLASSIFIED AS A MDDS AND REMOVED FROM THE DEVICE REGISTRATION AND LISTINGS FOR AGFA HEALTHCARE PER FDA'S ADVICE. THE ROOT CAUSE OF THE INCIDENT CANNOT BE DETERMINED BECAUSE THE AUDIO FILE WAS NOT AVAILABLE ANYMORE. THERE IS NO EVIDENCE THAT THE SYSTEM FAILED (I.E. THAT THE WORD "NO" WAS NOT RECOGNIZED / WAS DROPPED). THERE IS ALSO NO EVIDENCE THAT A MACRO WAS USED. IT COULD BE THAT THE USER STARTED SPEAKING BEFORE THE SYSTEM HAD A CHANCE TO ACCEPT THE COMMAND ISSUED BY PUSHING THE RECORD BUTTON. THE ONLY REPORTED HARM HAS BEEN ON THIS ONE PATIENT FOR UNNECESSARY MEDICAL TREATMENT AS DESCRIBED ABOVE. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147343 TALKSTATION OUG AGFA HEALTHCARE N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention