BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP6 VOLUME VENTILATOR

    MDR report key: 41884 · Received September 26, 1996

    Report

    Report Number
    2183157-1996-00038
    Event Type
    Malfunction
    Date Received
    September 26, 1996
    Date of Event
    August 28, 1996
    Report Date
    August 28, 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 LIQUID IN PT PRESSURE TUBE. DEVICE RETURNED UNREPAIRED AT CUSTOMER'S REQUEST. MFR INFORMED CUSTOMER THAT IT DOES NOT RECOMMEND DEVICE FOR PT USE UNTIL PROPER REPAIRS HAVE BEEN PERFORMED BY AUTHORIZED PERSONNEL. MFR DISABLED DEVICE PRIOR TO RETURNING IT TO CUSTOMER.

    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