BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP10 VOLUME VENTILATOR

    MDR report key: 38838 · Received September 5, 1996

    Report

    Report Number
    2183157-1996-00009
    Event Type
    Malfunction
    Date Received
    September 5, 1996
    Report Date
    August 6, 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
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    F.12) MFR NOT REQUIRED TO COMPLETE THIS SECTION AS NO MEDWATCH FORM 3500A WAS RECEIVED FROM USER/DISTRIBUTOR.

    Description of Event or Problem · 1

    REPORT OF ALLEGED "VENTILATOR HAS CONSTANT ALARM IN ASSIST CONTROL, NO LIGHTS, DOESNT CYCLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LP10 VOLUME VENTILATOR VOLUME VENTILATOR CBK AEQUITRON MEDICAL, INC. LP10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other