BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONETICS LTV 950

    MDR report key: 1084303 · Received July 31, 2008

    Report

    Report Number
    MW5007820
    Event Type
    Death
    Date Received
    July 31, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 23, 2008
    Manufacturer
    PULMONETICS SYSTEMS
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    POLICE CALLED TO INFORM US OF PT DEATH WHILE CONNECTED TO OUR VENTILATOR. THEY REPORTED THAT POWER FAILURE IN NEIGHBORHOOD CAUSED VENT TO ALARM, DAD SWITCHED POWER SOURCE TO EXTERNAL BATTERY AND WENT BACK TO BED. PERSONAL CARE ATTENDANT FOUND CHILD TO BE EXPIRED AND VENT NOT FUNCTIONING ABOUT 1 HR. 10 MIN AFTER DAD SWITCHED POWER OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETICS LTV 950 VENTILATOR CBK PULMONETICS SYSTEMS LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death