BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP10 VOLUME VENTILLATOR

    MDR report key: 251920 · Received November 24, 1999

    Report

    Report Number
    2183157-1999-00279
    Event Type
    Malfunction
    Date Received
    November 24, 1999
    Date of Event
    October 25, 1999
    Report Date
    November 24, 1999
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A CALL FROM A REPRESENTATIVE OF FACILITY ON 10/25/1999. FACILITY CALLED TO REPORT THE FOLLOWING PROBLEM: ALL LEDS WITH CONSTANT SINGLE TONE ALARM. UNIT RESETS WHEN UNIT IS TURNED OFF AND THEN ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LP10 VOLUME VENTILLATOR VOLUME VENTILLATOR CBK NELLCOR PURITAN BENNETT LP10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other