BEUDAMED
    FDA Adverse Event Other Summary report: N

    P.K. MORGAN

    MDR report key: 19222 · Received August 11, 1993

    Report

    Report Number
    19222
    Event Type
    Other
    Date Received
    August 11, 1993
    Date of Event
    June 17, 1993
    Report Date
    June 22, 1993
    Manufacturer
    P.K. MORGAN INSTRUMENTS, INC.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    EQUIPMENT FAILURE, NO INJURY TO PATIENT OR LAB OPERATOR. GAS FILL SAFETY VALVE FAILED, TEST RESOURCE OVERFILLED. OPERATOR WAS AWARE & REMOVED PATIENT FROM TEST AREA INTO HALLWAY. PLASTIC COVER OVER GAS CONTAINER SHATTERED. TESTING DISCONTINUED. EQUIPMENT MANUFACTURER NOTIFIED IMMEDIATELY. MODIFICATION TO PREVENT REOCCURRANCE SHIPPED & INSTALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P.K. MORGAN DIFFUSION BOX - AUTO LINK PULMOUARY FUNCTION TEST SYSTEM P.K. MORGAN INSTRUMENTS, INC. T.T. AUTO LINK N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other