BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP6+VOLUME VENTILATOR

    MDR report key: 185380 · Received August 31, 1998

    Report

    Report Number
    2183157-1998-00145
    Event Type
    Malfunction
    Date Received
    August 31, 1998
    Date of Event
    August 3, 1998
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A CALL ON 08/03/1998. CALLED TO REPORT THE FOLLOWING PROBLEM: WON'T CYCLE WITH LOW PRESSURE LED AND NO AUDIBLE 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 UNKNOWN Other