BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAGNETIC PEEP VALVE

    MDR report key: 280563 · Received June 1, 2000

    Report

    Report Number
    MW1019057
    Event Type
    Other
    Date Received
    June 1, 2000
    Date of Event
    March 10, 2000
    Report Date
    May 23, 2000
    Manufacturer
    INSTRUMENTATION INDUSTRIES INC.
    Product Code
    BYE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    POSITIVE END EXPIRATORY PRESSURE (PEEP) VALVE WAS ATTACHED TO THE ENDOTRACHEAL TUBE IN A METHOD WHICH DID NOT ALLOW ADEQUATE VENTILATION. THE DESIGN OF THE PEEP VALVE MAY HAVE ALLOWED INAPPROPRIATE APPLICATION OF THE DEVICE TO OCCUR IN THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNETIC PEEP VALVE REUSABLE ADJUSTABLE MAGNETIC PEEP VALVE BYE INSTRUMENTATION INDUSTRIES INC. BE 142 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other OHMEDA VENTILATOR.