BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP6+ VOLUME VENTILATOR

    MDR report key: 221400 · Received April 27, 1999

    Report

    Report Number
    2183157-1999-00098
    Event Type
    Malfunction
    Date Received
    April 27, 1999
    Date of Event
    April 9, 1999
    Report Date
    April 27, 1999
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A CALL FROM A RT WITH "PSA" ON 04/09/1999. THE RT CALLED TO REPORT THE FOLLOWING PROBLEM: NO VOLUME DELIVERED WITH ALL LEDS ON AND CONSTANT SINGLE TONE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LP6+ VOLUME VENTILATOR VOLUME VENTILATOR CBK NELLCOR PURITAN BENNETT LP6+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other