BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KORA

    MDR report key: 3962736 · Received July 29, 2014

    Report

    Report Number
    1000165971-2014-00426
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY SORIN THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES.

    Description of Event or Problem · 1

    THE DEVICE HAS SWITCHED TO STANDBY MODE BETWEEN THE 17THS AND 20THS SESSION OF RADIOTHERAPY ON CHEST AREA. THE DEVICE HAS BEEN RE-INITIALIZED SUCCESSFULLY ON (B)(6) 2014. AN ANALYSIS AND PATIENT CARE RECOMMENDATIONS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441178 KORA NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY KORA 100 DR 2804

    Patients

    Seq Age Sex Outcome Treatment
    1