BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPLUS HUMIDFIER CARTRIDGE/CIRCUIT

    MDR report key: 302724 · Received October 25, 2000

    Report

    Report Number
    1719232-2000-00008
    Event Type
    Malfunction
    Date Received
    October 25, 2000
    Date of Event
    August 2, 2000
    Report Date
    October 24, 2000
    Manufacturer
    BUNNELL INC
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR SYSTEM ALARMED, "HUMIDIFIER ALARM". THE HUMIDIFIER CARTRIDGE/CIRCUIT WAS REPLACED AND OPERATION RESUMED AS NORMAL. NO HARM OR INJURY TO PT. NOTE: NORMALLY THIS IS A NON REPORTABLE EVENT. HOWEVER, BUNNELL RECEIVED A MEDWATCH REPORT FROM THE USERS FACILITY, AND PER THE CO'S INTERNAL PROCEDURES ALL THIRD PARTY REPORTS ARE AUTOMATICALLY A REPORTABLE EVENT. DATE OF EVENT WAS 2000, HOWEVER, THE CO HAD NOT RECEIVED THE MEDWATCH REPORT FROM THE USER FACILITY UNTIL 2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPLUS HUMIDFIER CARTRIDGE/CIRCUIT VENTILATOR/HUMIDIFIER CARTRIDGE CBK BUNNELL INC NA 0D0070

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN