BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX-PRO

    MDR report key: 349500 · Received August 14, 2001

    Report

    Report Number
    MW1022729
    Event Type
    Malfunction
    Date Received
    August 14, 2001
    Report Date
    August 13, 2001
    Manufacturer
    PMX MEDICAL
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NO INFORMATION

    Narratives

    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
    36859 MX-PRO RESERVOIR BAG, MASK AND MANOMETER AND/OR PEEP BTM PMX MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *