BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM LATITUDE

    MDR report key: 9668060 · Received February 4, 2020

    Report

    Report Number
    2124215-2019-28993
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    October 16, 2019
    Report Date
    February 4, 2020
    Manufacturer
    BENCHMARK
    Product Code
    LWS
    UDI-DI
    00802526564703
    PMA / PMN Number
    P910077/S046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. ADDITIONAL ANALYSIS NOT REQUIRED BECAUSE IT IS NOT MDR/MDV REPORTABLE OR ALLEGATION IS NOT SOFTWARE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PROGRAMMER EMITTED BLUE FUME AND STARTED SMOKING. THE PROGRAMMER WAS NO LONGER IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127130 ZOOM LATITUDE PROGRAMMER LWS BENCHMARK 3120 058151 00802526564703

    Patients

    Seq Age Sex Outcome Treatment
    1