BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMIS 100 VPAP ST FR

    MDR report key: 7115917 · Received December 13, 2017

    Report

    Report Number
    3004604967-2017-01770
    Event Type
    Death
    Date Received
    December 13, 2017
    Report Date
    January 4, 2018
    Manufacturer
    RESMED LTD
    Product Code
    MNS
    PMA / PMN Number
    K123511
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LUMIS DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. PRELIMINARY INVESTIGATION FOUND NO ERRORS INDICATING A DEVICE MALFUNCTION IN THE DEVICE LOGS AND ALL PERFORMANCE TESTS SHOWED THAT THE DEVICE WAS OPERATING TO SPECIFICATION. THERE WAS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    THE LUMIS DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE LOGS AND PERFORMANCE TESTING FOUND NO INDICATION OF A DEVICE MALFUNCTION AND THE DEVICE WAS PERFORMING TO SPECIFICATIONS. BASED ON ALL AVAILABLE EVIDENCE, THE INVESTIGATION DETERMINED THAT THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. RESMED'S RISK ANALYSIS FOR THIS DEVICE REMAINS ACCEPTABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PATIENT ON A LUMIS 100 VPAP ST FR PASSED AWAY. THE PATIENT WAS REPORTED TO HAVE STOPPED BREATHING WHILE ON THE DEVICE. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION OR THAT THE DEVICE CONTRIBUTED TO THE PATIENT DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PATIENT ON A LUMIS 100 VPAP ST FR PASSED AWAY. THE PATIENT WAS REPORTED TO HAVE STOPPED BREATHING WHILE ON THE DEVICE. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION OR THAT THE DEVICE CONTRIBUTED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891851 LUMIS 100 VPAP ST FR MNS RESMED LTD 28102

    Patients

    Seq Age Sex Outcome Treatment
    1 Death