BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SRT-100 VISION

    MDR report key: 18231368 · Received November 29, 2023

    Report

    Report Number
    3008513398-2023-00002
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    November 14, 2023
    Report Date
    November 29, 2023
    Manufacturer
    SENSUS HEALTHCARE INC.
    Product Code
    JAD
    PMA / PMN Number
    K150037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION DETERMINED THE SYTEM IS WORKING WITHIN SPECIFICATIONS. PATIENT EVALUATION IS ONGOING WITH THE RESPONSIBLE PHYSICIAN.THIS REPORT WILL BE UPDATED WITH THE RESULTS OF THE PATIENT IMPACT EVALUATION.

    Description of Event or Problem · 0

    SENSUS RECEIVE THE REPORT OF A POTENTIAL PATIENT OVERDOSE AT THIS USER FACILITY, INVESTIGATION DETERMINED THAT THE SYSTEM WAS OPERATING WITHIN SPECIFICATIONS AT ALL TIMES. SENSUS IS INVESTIGATING THIS ISSUE WITH THE RESPONSIBLE PHYSICIAN AND WILL UPDATE THIS MDR FILE WHEN FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919707 SRT-100 VISION X-RAY RADIATION THERAPY SYSTEM JAD SENSUS HEALTHCARE INC. SRT-100-VISION N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Other