BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP6+ VOLUME VENTILATOR

    MDR report key: 197902 · Received November 16, 1998

    Report

    Report Number
    2183157-1998-00209
    Event Type
    Malfunction
    Date Received
    November 16, 1998
    Date of Event
    October 17, 1998
    Report Date
    November 16, 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 SVC OF PRODUCT A WON'T CYCLE CONDITION WITH ALL LIGHT-EMITTING DIODES AND CONSTANT SINGLE TONE ALARM WAS FOUND, DUE TO INTEGRATED CIRCUIT U28 ON THE LOGIC BOARD BEING OUT OF SPEC. 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 * Other