BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP10 VOLUME VENTILATOR

    MDR report key: 207082 · Received January 13, 1999

    Report

    Report Number
    2183157-1999-00013
    Event Type
    Malfunction
    Date Received
    January 13, 1999
    Date of Event
    December 17, 1998
    Report Date
    January 12, 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 SVC, THE UNIT WAS FOUND TO STOP CYCLE WITH ALL LEDS AND A CONSTANT SINGLE TONE AUDIBLE ALARM, DUE TO INTEGRATED CIRCUIT U28 ON THE LOGIC BOARD BEING OUT OF SPECIFICATIONS. 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