BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP10 VOLUME VENTILATOR

    MDR report key: 209416 · Received February 5, 1999

    Report

    Report Number
    2183157-1999-00036
    Event Type
    Malfunction
    Date Received
    February 5, 1999
    Date of Event
    January 19, 1999
    Report Date
    February 5, 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
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SERVICE THE UNIT WAS FOUND TO STOP CYCLE WITH ALL LEDS AND CONSTANT SINGLE TONE ALARM, DUE TO INTERGRATED 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