BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP6 VOLUME VENTILATOR

    MDR report key: 39909 · Received September 6, 1996

    Report

    Report Number
    2183157-1996-00016
    Event Type
    Malfunction
    Date Received
    September 6, 1996
    Report Date
    August 8, 1996
    Manufacturer
    AEQUITRON MEDICAL, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SERVICE OF PRODUCT A POTENTIAL NO LOW PRESSURE ALARM CONDITION WAS FOUND DUE TO TRANSDUCER BEING OUT OF SPECIFICATION. REPLACED TRANSDUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LP6 VOLUME VENTILATOR VOLUME VENTILATOR CBK AEQUITRON MEDICAL, INC. LP6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other