BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP10 VOLUME VENTILATOR

    MDR report key: 163805 · Received April 17, 1998

    Report

    Report Number
    2183157-1998-00065
    Event Type
    Malfunction
    Date Received
    April 17, 1998
    Date of Event
    March 26, 1998
    Report Date
    April 17, 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

    TESTING BY MFR FOUND UNIT TO NOT CYCLE WITH ALL LEDS AND CONSTANT SINGLE TONE ALARM 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 LP10 VOLUME VENTILATOR VOLUME VENTILATOR CBK NELLCOR PURITAN BENNETT LP10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other