BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 416983 · Received September 12, 2002

    Report

    Report Number
    2031702-2002-00140
    Event Type
    Malfunction
    Date Received
    September 12, 2002
    Report Date
    September 11, 2002
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PULMONETIC SYSTEMS, INC. RECEIVED A REPORT FROM SERVICE CENTER ON 8/12/2002. THE REPORT STATED THE FOLLOWING PROBLEM: DEFECTIVE MOTOR BOARD, TURBINE DOES NOT RUN. UNIT WAS SENT TO SERVICE CENTER FOR 2 YEARS PREVENTATIVE MAINTENANCE.

    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