BEUDAMED
    FDA Adverse Event Death Summary report: N

    PVV VENTILATOR, 20-YEAR LEASE

    MDR report key: 442212 · Received February 7, 2003

    Report

    Report Number
    2518422-2003-00008
    Event Type
    Death
    Date Received
    February 7, 2003
    Date of Event
    January 3, 2003
    Report Date
    January 8, 2003
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INFO WAS REC'D THAT A PT ALLEGEDLY EXPIRED WHILE ON THIS UNIT. IT WAS REPORTED TO THE PARTICIPATING RT FROM THE PT'S FAMILY MEMBER THAT THE "UNIT FAILED". A COPY OF THE CORONER'S REPORT IS ON ORDER WITH THE PARTICIPATING RT. THE VENT AND ALARM SETTINGS AT THE TIME OF THE EVENT ARE UNKNOWN. AN EVAL OF THE UNIT BY RESPIRONICS HAS NOT BEEN PERFORMED AT THIS TIME AND EFFORTS TO OBTAIN THE EQUIPMENT HAVE BEEN UNSUCCESSFUL. THE MOST RECENT INFORMATION REGARDING THE UNIT'S CONDITION WAS THAT IT WAS IN FOR REPAIR AND PREVENTATIVE MAINTENANCE ON 12/27/2002. IT WAS RUN IN FOR 65 HOURS AND PASSED FINAL INSPECTION AS THE UNIT WAS FUNCTIONING TO ALL REQUIRED SPECS. IT IS UNKNOWN AT THIS TIME WHETHER A DEVICE FAILURE HAD ACTUALLY OCCURRED AND IF SO, WHETHER THERE WAS ANY ASSOCIATION BETWEEN ANY SUCH FAILURE AND THE PT EXPIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PVV VENTILATOR, 20-YEAR LEASE PORTABLE VOLUME VENTILATOR CBK RESPIRONICS, INC. 33001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death