BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 7078305 · Received December 4, 2017

    Report

    Report Number
    2950347-2017-00004
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Report Date
    January 25, 2021
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 (B)(6) 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 17-MAR-2017.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ONE TREATMENT FOR A PATIENT HAS NOT BEEN RECORDED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861018 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown