BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 536300 · Received March 17, 2004

    Report

    Report Number
    2031702-2004-00044
    Event Type
    Malfunction
    Date Received
    March 17, 2004
    Date of Event
    February 9, 2004
    Report Date
    March 17, 2004
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004 20:45, REPORTED BY THE CUSTOMER. ON A PT AT THE TIME OF THE EVENT. THE VENTILATOR ALARMED - LN VENT1 ALARM WITH SOUND. THE PRIMARY POWER SOURCE USED WITH THE VENT WAS AC ADAPTER. THE POWER SOURCE THE VENTILATOR WAS ON AT THE TIME OF THE EVENT WAS AC ADAPTER. UNK HOW LONG THE VENTILATOR WAS ON THIS POWER SOURCE PRIOR TO THE EVENT. NO ADD'L POWER SOURCES WERE TRIED. UNK IF THERE ARE ALLEGATIONS OF THE VENTILATOR CAUSING PT HARM. THE EVENT OCCURRED IN HOSP. A HEALTH CARE PROF WAS PRESENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK PULMONETIC SYSTEMS, INC. LTV 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other