BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX DIAMOND VALVE KIT

    MDR report key: 254236 · Received December 8, 1999

    Report

    Report Number
    2518608-1999-00001
    Event Type
    Malfunction
    Date Received
    December 8, 1999
    Date of Event
    June 23, 1999
    Report Date
    November 17, 1999
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    11/17/99 - VALVE WAS RETURNED TO MFR FOR EVALUATION - REPORTED PROBLEM FROM HOSP "VENTRICULO-PERITONEAL SHUNT MALFUNCTION". 11/30/99 - RETURNED VALVE WAS VISUALLY EXAMINED AND STERILIZED PRIOR TO BEING TESTED ACCORDING TO MFG SPEC. THE PRESSURE/FLOW PERFORMANCE CHARACTERISTICS OF THE VALVE WERE TESTED. THE VALVE WAS DISASSEMBLED AND EXAMINED UNDER A MICROSCOPE FOR DEFECTS. INITIAL NON-MAGNIFIED VISUAL EXAMINATION DID NOT SHOW DEFECTS, BUT THE VALVE WAS COVERED WITH BLOOD AND DEBRIS. THE PRESSURE FLOW CHARACTERISTICS OF THE VALVE WERE SIMILAR TO THE PERFORMANCE CHARACTERISTICS OF THE HIGH PRESSURE VALVE, WHICH IS INDICATIVE OF AN OBSTRUCTION OF THE SLIT SLEEVE APERTURE. WHEN THE VALVE WAS DISASSEMBLED, AND MEASURED UNDER 63X MAGNIFICATION, IT WAS EVIDENT THAT THE MEASUREMENT OF THE SLIT WAS BELOW SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX DIAMOND VALVE KIT Implant VENTRICULO-PERITONEAL HYDROCEPHALIC SHUNT JXG PHOENIX BIOMEDICAL CORP. NA B27

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other