BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP6+ VOLUME VENTILATOR

    MDR report key: 205975 · Received January 6, 1999

    Report

    Report Number
    2183157-1999-00003
    Event Type
    Malfunction
    Date Received
    January 6, 1999
    Date of Event
    December 8, 1998
    Report Date
    January 6, 1999
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT REC'D A CALL ON 12/08/1998. SOURCE CALLED TO REPORT THE FOLLOWING PROBLEM: INTERMITTENT STOP CYCLE. FOUND DURING BENCH TEST.

    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