BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXH VLV ASSY, PED, MILL, ENGLISH

    MDR report key: 1016373 · Received March 13, 2008

    Report

    Report Number
    2020676-2008-00003
    Event Type
    Other
    Date Received
    March 13, 2008
    Date of Event
    February 4, 2008
    Report Date
    March 13, 2008
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    APPEARS TO BE USER ERROR. FOLLOW UP REPORT WILL BE SUBMITTED FOR EVALUATION.

    Description of Event or Problem · 1

    DISTRIBUTOR IN (B) (4) REPORTED THAT CUSTOMER AT HOSPITAL APPARENTLY ATTEMPTED TO USE VENTILATOR WITH REFERENCE PRESSURE LINE STUCK INTO A THREADED HOLE IN THE FRONT OF THE PEDIATRIC EXHALATION BLOCK. THE PEDIATRIC EXHALATION BLOCK IS USED TO VENTILATE PTS RANGING FROM 10 LBS TO 100 LBS, NOT NEONATES OR PREMATURE INFANTS. THE THREADED HOLE IS PLUGGED WITH AT LEAST TWO SETSCREWS TO PREVENT FULL INSERTION OF THE SENSE LINE. THE REFERENCE PRESSURE CONNECTOR IS DESIGNED TO BE A TAPERED SLIP FIT INTO A SMOOTH SIDE TAPERED HOLE IN THE LOWER FRONT OF THE BLOCK. THE BLOCK LABEL CLEARLY IDENTIFIES THE HOLES THE PROXIMAL LINE, REFERENCE PRESSURE LINE AND "FROM PT" HOSE CONNECTIONS ARE TO BE MADE INTO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXH VLV ASSY, PED, MILL, ENGLISH PEDIATRIC EXHALATION VALVE CBP SECHRIST INDUSTRIES, INC. 21442-1

    Patients

    Seq Age Sex Outcome Treatment
    1