BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSUS HEALTHCARE SRT-100 VISION

    MDR report key: 15848708 · Received November 22, 2022

    Report

    Report Number
    3008513398-2022-00001
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    March 3, 2022
    Report Date
    November 22, 2022
    Manufacturer
    SENSUS HEALTHCARE, INC
    Product Code
    JAD
    PMA / PMN Number
    K150037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON AWARENESS OF THIS EVENT FOR SERIAL NUMBER (B)(4), SENSUS IMMEDIATELY DEPLOYED A SERVICE ENGINEER TO INSPECT THE SYSTEM. SENSUS HAD NO RECORD OF CALL OR COMPLAINTS FROM THE PATIENT IN QUESTION, LISTED IN (B)(4), OR FROM THE FACILITY THAT WAS OPERATING THE DEVICE. SYSTEM EVALUATION PERFORMED ON (B)(6) 2022 DETERMINED SYSTEM WAS OPERATING TO FULL FACTORY SPECS. A COPY OF THE SYSTEM'S ANNUAL CALIBRATION, PERFORMED ON (B)(6) 2022, DETERMINED THE SYSTEM OUTPUT WAS COMPARABLE TO SYSTEM COMMISSION DATA WITH MINIMAL DEVIATION (SEE ATTACHED CALIBRATION DATA REPORT). A FULL REVIEW OF THE INITIAL MANUFACTURING RECORDS WAS PERFORMED AND FOUND NO ISSUES OR SAFETY ANOMALIES OCCURED DURING PRODUCTION (SEE ATTACHED DHR). A REVIEW OF THE SYSTEM SERVICE RECORDS FOUND THE SYSTEM TO BE IN GOOD WORKING ORDER AND CONCLUDED SYSTEM MET ALL SAFETY REQUIREMENTS AND SPECIFICATIONS.

    Description of Event or Problem · 0

    SENSUS HEALTHCARE WAS MADE AWARE OF AN MDR EVENT THROUGH FDA'S MEDWATCH PROGRAM, (B)(4). THE EVENT STATED A PATIENT SUBMITTED A VOLUNTARY REPORT REGARDING AN ADVERSE EVENT THAT OCCURRED ON (B)(6) 2022. PATIENT WAS UNDERGOING TREATMENT FOR SQUAMOUS CELL CARCINOMA. PATIENT IS A 67-YEAR-OLD ACTIVE MALE AND IS NOT DIABETIC. PATIENT RECEIVED 20 TREATMENTS AT 3 TREATMENTS PER WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368099 SENSUS HEALTHCARE SRT-100 VISION SYSTEM, THERAPEUTIC, X-RAY JAD SENSUS HEALTHCARE, INC SRT-100 VISION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Other