BEUDAMED
    FDA Adverse Event Death Summary report: N

    LP SERIES HOME VENTILATOR

    MDR report key: 2172683 · Received July 20, 2011

    Report

    Report Number
    2183157-2011-00001
    Event Type
    Death
    Date Received
    July 20, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 20, 2011
    Manufacturer
    PLAINFIELD (LP)
    Product Code
    CBK
    PMA / PMN Number
    K903010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LP-10 VENTILATOR DOES NOT HAVE THE CAPABILITY TO PROVIDE A MEMORY DOWNLOAD. SHOULD NEW INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    COVIDIEN, RECEIVED A CALL INQUIRING ABOUT VENTILATOR DOWNLOAD. AS PER CALLER, THE VENTILATOR WAS FOUND POWERED ON AND IN STANDBY MODE. THE PT CIRCUIT WAS STILL ATTACHED TO THE PT AND TO THE VENTILATOR AT THE TIME OF THE EVENT. AS PER CALLER, THERE IS NO ALLEGATION OF A VENTILATOR MALFUNCTION OR THAT IT CONTRIBUTED TO THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LP SERIES HOME VENTILATOR VENTILATOR CONTINUOUS CBK PLAINFIELD (LP) LP10

    Patients

    Seq Age Sex Outcome Treatment
    1 Death