BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 7288245 · Received February 22, 2018

    Report

    Report Number
    2950347-2017-00010
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    May 23, 2017
    Report Date
    January 25, 2021
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED. IT WAS REQUESTED BY FDA MEDWATCH PROGRAM DEPARTMENT ON 15-JAN-2021 TO RE-SUBMIT THIS FORM 3500A AS THERE WAS NO RECORD OF THE INITIAL REPORT SUBMISSION IN THE EMDR SYSTEM. THE INFORMATION CONTAINED IN THIS INITIAL REPORT WAS CORRECT AT THE TIME IT WAS ORIGINALLY SUBMITTED ON 29-JUN-2017.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ISSUES WITH MANUALLY LOADING FIELDS IN MOSAIQ. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN AN ACTUAL MISTREATMENT. DURING ONE FRACTION OF A COURSE OF TREATMENT A TREATMENT FIELD WAS DELIVERED TO AN INCORRECT SITE. THE FIELD WAS INTENDED FOR THE RIGHT NECK BUT WAS DELIVERED TO THE LEFT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134701 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other