BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUCAS

    MDR report key: 4856149 · Received June 15, 2015

    Report

    Report Number
    MW5043116
    Event Type
    Other
    Date Received
    June 15, 2015
    Date of Event
    June 6, 2015
    Report Date
    June 15, 2015
    Manufacturer
    PHYSIO CONTROL
    Product Code
    DRM
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SUCTION CUP ON LUCAS DEVICE WAS NOT SEATED CORRECTLY. IT WAS NOTICED AFTER THE DEVICE WAS REMOVED AFTER THE PT WAS DECLARED DEAD THAT THE SUCTION CAP HAD CAUSED SOFT TISSUE DAMAGE TO THE ANTERIOR CHEST SKIN AND PERHAPS MUSCLE LAYER. THE DAMAGE WAS MORE THAN IS USUALLY NOTED AFTER LUCAS REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388709 LUCAS NONE DRM PHYSIO CONTROL LUCAS 2 100582-01

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other