BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTISURE WITH RESERVOIR BAG, MASK & MANOMETER

    MDR report key: 347619 · Received August 13, 2001

    Report

    Report Number
    MW1022634
    Event Type
    Malfunction
    Date Received
    August 13, 2001
    Report Date
    August 13, 2001
    Manufacturer
    ENGINEERED MEDICAL SYSTEMS, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 9/13/01: IN RESPONSE TO NOTIFICATION OF AN ANONYMOUS COMPLAINT CONCERNING RESUSCITATORS, MFR MUST DIFFERENTIATE BETWEEN THE RESUSCITATORS INCLUDED. WHILE ALL THREE RESUSCITATORS MENTIONED DO HAVE THE SAME TYPE OF VALVING AND ALL THREE ARE PREDOMINATELY PRODUCED BY ENGINEERED MEDICAL SYSTEMS (EMS), THE VENTISURE IS A RELATIVELY NEW PRODUCT LINE MFG EXCLUSIVELY BY EMS AND IS DISTRIBUTED BY TRI-ANIM; THE PMX RESUSCITATOR LINE IS ALSO MFG EXCLUSIVELY BY EMS AND IS DISTRIBUTED BY PMX MEDICAL. THE ALLEGIANCE RESUSCITATOR LINE IS MFG AND DISTRIBUTED BY ALLEGIANCE, WITH EMS AS THE CONTRACT MFR FOR A PORTION OF THIS LINE. ANY QUESTIONS CONCERNING THE ALLEGIANCE LINE NEED TO BE ADDRESSED BY ALLEGIANCE HEALTHCARE. WITH RESPECT TO THE ALLEGATION THAT THE RESUSCITATORS DO NOT MEET THE ASTM STANDARDS (WHICH STANDARDS REFERRED TO ARE UNK), EMS TESTS 100% OF ITS RESUSCITATORS FOR BOTH INHALATION AND EXHALATION PER ASTM STANDARD F 920-93, AND HAS BEEN SINCE THE INCEPTION OF RESUSCITATOR PROGRAM. TEST DATA IS KEPT AND IS AVAILABLE FOR REVIEW TO THE FDA. THERE IS NO BASIS FOR THIS ALLEGATION. MFR DOES NOT KNOW WHO OR WHERE THIS ANONYMOUS COMPLAINT CAME FROM BUT IT IS AWARE THAT THE VENTISURE LINE, WHICH INCLUDES CO2 INDICATION, HAS MADE SIGNIFICANT INROADS INTO THE CURRENT SALES MIX IN THE HOSP AND PRE-HOSP AREAS. THERE MAY BE NOTHING MORE TO THIS ALLEGATION THAN AN ATTEMPT TO AFFECT PRODUCT SALES. NEITHER THE ALLEGIANCE PRODUCTS NOR THE PMX PRODUCTS INCLUDE CO2 INDICATION.

    Description of Event or Problem · 1

    ALL HAVE SAME VALVING, VALVE BODY # 4251A, NONE MEET ASTM STANDARDS. HIGH EXPIRATORY RESISTANCE, HIGH INSPIRATORY RESISTANCE, "AUTO PEEP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36508 VENTISURE WITH RESERVOIR BAG, MASK & MANOMETER INFANT BTM ENGINEERED MEDICAL SYSTEMS, INC. * *
    36509 VENTISURE WITH RESERVOIR BAG, MASK & MANOMETER PEDIATRIC BTM ENGINEERED MEDICAL SYSTEMS, INC. * *
    36510 VENTISURE WITH RESERVOIR BAG & MASK ADULT BTM ENGINEERED MEDICAL SYSTEMS, INC. * *
    36511 VENTISURE WITH RESERVOIR BAG & MASK LARGE ADULT BTM ENGINEERED MEDICAL SYSTEMS, INC. * *
    36512 VENTISURE WITH RESERVOIR BAG, MASK, MANOMETER & PEEP INFANT BTM ENGINEERED MEDICAL SYSTEMS, INC. * *
    36513 VENTISURE WITH RESERVOIR BAG, MASK, MANOMETER & PEEP PEDIATRIC BTM ENGINEERED MEDICAL SYSTEMS, INC. * *
    36514 VENTISURE WITH RESERVOIR BAG, MASK & PEEP ADULT BTM ENGINEERED MEDICAL SYSTEMS, INC. * *
    36515 VENTISURE WITH RESERVOIR BAG, MASK & PEEP LARGE ADULT BTM ENGINEERED MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *