BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP10 VOLUME VENTILATOR

    MDR report key: 212425 · Received February 26, 1999

    Report

    Report Number
    2183157-1999-00055
    Event Type
    Malfunction
    Date Received
    February 26, 1999
    Date of Event
    February 9, 1999
    Report Date
    February 25, 1999
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING TESTING THE UNIT WAS FOUND TO STOP CYCLE WITH ALL LEDS AND CONSTANT SINGLE TONE ALARM DUE TO INTGREATED CIRCUIT U28, U27, AND U24 ON THE LOGIC CIRCUIT BOARD BEING OUT OF SPECIFICATION. A MOTOR STALL WITH LOW PRESSURE ALARM WAS ALSO FOUND DUE TO INTEGRATED CIRCUIT U10 ON THE MOTOR BOARD BEING OUT OF SPECIFICATION. REPLACED U28, U27, U24, AND U10.

    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