BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP6 VOLUME VENTILATOR

    MDR report key: 40604 · Received September 11, 1996

    Report

    Report Number
    2183157-1996-00020
    Event Type
    Malfunction
    Date Received
    September 11, 1996
    Report Date
    August 12, 1996
    Manufacturer
    AEQUITRON MEDICAL, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT OF ALLEGED "UNIT DOES NOT CYCLE. ALARMS LOW POWER ON AC POWER. NO PT HARM." TESTING BY MFR FOUND A MOTOR STALL, WITH AUDIBLE LOW PRESSURE ALARM, DUE TO TRANSISTORS Q2 AND Q6 OR THE MOTOR BOARD BEING OUT OF SPEC. REPLACED Q2 AND Q6.

    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