BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP10 VOLUME VENTILATOR

    MDR report key: 235133 · Received August 6, 1999

    Report

    Report Number
    2183157-1999-00164
    Event Type
    Malfunction
    Date Received
    August 6, 1999
    Date of Event
    July 6, 1999
    Report Date
    August 5, 1999
    Manufacturer
    NELLCOR PURITAN BENNETT, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A CALL FROM A REP. ON 07/06/1999. REP CALLED TO REPORT THE FOLLOWING PROBLEM: ALL LEDS ON , CONSTANT SINGLE TONE ALARM, NO VOLUME DELIVRED. CAN BE REPEATED ON BOTH AC OR DC POWER. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LP10 VOLUME VENTILATOR VOLUME VENTILATOR CBK NELLCOR PURITAN BENNETT, INC. LP10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other