BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP6+ VOLUME VENTILATOR

    MDR report key: 145143 · Received January 15, 1998

    Report

    Report Number
    2183157-1998-00010
    Event Type
    Malfunction
    Date Received
    January 15, 1998
    Date of Event
    December 15, 1997
    Report Date
    January 14, 1998
    Manufacturer
    NELLCOR PURITAN BENNETT, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TESTING BY MFR FOUND THE DEVICE WOULD NOT CYCLE WITH ALL LEDS AND CONSTANT SINGLE TONE ALARM DUE TO INTEGRATED CIRCUIT U28 ON THE LOGIC BOARD. REPLACED U28.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LP6+ VOLUME VENTILATOR VOLUME VENTILATOR CBK NELLCOR PURITAN BENNETT, INC. LP6+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other