BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP6+ VOLUME VENTILATOR

    MDR report key: 205969 · Received January 6, 1999

    Report

    Report Number
    2183157-1999-00005
    Event Type
    Malfunction
    Date Received
    January 6, 1999
    Date of Event
    December 11, 1998
    Report Date
    January 6, 1999
    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 SVC OF UNIT A STOP CYCLE WITH ALL LEDS AND CONSTANT SINGLE TONE ALARM WAS FOUND, DUE TO INTEGRATED CIRCUIT U28 ON THE LOGIC BOARD BEING OUT OF SPECIFICATION. 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