BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP6+ VOLUME VENTILATOR

    MDR report key: 183015 · Received August 13, 1998

    Report

    Report Number
    2183157-1998-00124
    Event Type
    Malfunction
    Date Received
    August 13, 1998
    Date of Event
    July 9, 1998
    Report Date
    August 7, 1998
    Manufacturer
    NELLCOR PURITAN BENNETT
    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

    DURING SERVICE OF PRODUCT UNIT WAS FOUND TO NOT CYCLE WITH ALL LEDS ON AND CONSTANT SINGLE TONE AUDIBLE 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 LP6+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other