BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP6+ VOLUME VENTILATOR

    MDR report key: 149275 · Received February 11, 1998

    Report

    Report Number
    2183157-1998-00027
    Event Type
    Malfunction
    Date Received
    February 11, 1998
    Date of Event
    February 2, 1998
    Report Date
    February 2, 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

    ON FEBRUARY 2,1998, DURING SERVICE OF PRODUCT MANUFACTURER TESTING FOUND UNIT WOULD NOT CYCLE WITH ALL LEDS AND A 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 LP6+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other