BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI-TEC III INFILTRATOR

    MDR report key: 736919 · Received June 29, 2006

    Report

    Report Number
    2025576-2006-00004
    Event Type
    Malfunction
    Date Received
    June 29, 2006
    Date of Event
    February 9, 2006
    Report Date
    February 9, 2006
    Manufacturer
    BYRON MEDICAL, INC.
    Product Code
    DQI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL EVALUATION OF THE UNIT INDICATED THAT THE DEVICE HAD NO POWER WHEN PROPER CONNECTED. VISUAL EVALUATION REVEALED THAT THE THREE SCREWS ON THE BACK OF THE DEVICE WERE RUSTY, INDICATED THAT FLUID HAD BEEN IN THE LOCATION FOR SOME TIME. TWO OF THE THREE SCREWS UNDER THE CAM AND BEARING APPEAR TO HAVE BEEN REMOVED AS THEY WERE HITTING THE BOTTOM OF THE BEARING. THIS INDICATES THAT THE TOP OF THE UNIT HAD BEEN REMOVED AT ONE TIME. FURTHER ELECTRICAL EVALUATION REVEALED THAT, THE FUSE HAD BLOWN DUE TO WATER IN THE MOTOR. WATER CAN ONLY GET TO THIS AREA IF THE UNIT HAD BEEN IMMERSED IN LIQUID. PAGE 7 OF 12 IN OPERATIONS MANUAL INDICATES TO THE USER IN A WARNING STATEMENT NOT TO IMMERSE IN LIQUID, AND NOT TO OPEN THE CASE.

    Description of Event or Problem · 1

    THE DR. INDICATES THAT THE O.R. NURSE WENT TO ADJUST THE SETTING ON THE UNIT, AND IT GAVE HER A "SMALL ELECTRICAL JOLT". IMMEDIATELY AFTER, THE UNIT STOPPED WORKING COMPLETELY. THE SWITCH WILL NOT POWER UP THE UNIT OR THE FOOT PEDAL. THE DR. STATED THAT THIS WAS NOT A SIGNIFICANT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI-TEC III INFILTRATOR INFILTRATION PUMP DQI BYRON MEDICAL, INC. PT-PINF-III *

    Patients

    Seq Age Sex Outcome Treatment
    1 *