BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEH-4 LITHOTRIPTER

    MDR report key: 1071868 · Received July 9, 2008

    Report

    Report Number
    1450997-2008-08022
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    May 16, 2008
    Report Date
    July 9, 2008
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Product Code
    FFK
    PMA / PMN Number
    K923822
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THIS MACHINE WAS APPARENTLY DROPPED EARLIER THIS YEAR, AND RETURNED TO NORTHGATE TECHNOLOGIES INC. FOR SERVICE. THE DAMAGED CAUSED BY THE DROP WAS AS FOLLOWS: THE NYLON GROMMETS USED TO SECURE THE HV BOX WERE BROKEN ALLOWING THE HV BOX TO MOVE AROUND INSIDE THE CHASSIS CAUSING DAMAGE TO THE FUSE HOLDERS, RIBBON CABLE AND THE FILTER PANEL. THE NYLON SCREWS USED TO SECURE THE HV TRIGGER BOARD WERE BROKEN AND THE CPU PCB WAS DAMAGED. THE FUSE HOLDERS, NYLON GROMMETS, NYLON SCREWS, CPU PCB, AND THE FILTER PANEL WAS REPLACED. THE MACHINE WAS RECALIBRATED AND RETURNED TO THE CUSTOMER. ON APRIL 24, 2008, NORTHGATE TECHNOLOGIES INC. COMPLETED AND IMPLEMENTED CORRECTIVE ACTION WHICH INCLUDED REPLACING #8 SCREW WITH A #10 SCREW ON THE NYLON GROMMETS HOLDING THE HIGH VOLTAGE BOX ON ALL NEW AUTOLITH PRODUCTS AND ANY RETURNED AUTOLITH PRODUCTS THAT INCLUDE BROKEN GROMMETS. THE MACHINE WAS AGAIN RETURNED TO NORTHGATE TECHNOLOGIES INC. FOR SERVICE ON JUNE 12, 2008. DURING A VISUAL INSPECTION OF THE INTERIOR OF THE UNIT, IT WAS OBSERVED THAT THE WIRES EXITING THE HV BOX WERE FRAYED.

    Description of Event or Problem · 1

    DURING A BLADDER STONE LITHOTRIPSY PROCEDURE, THE ANESTHESIOLOGIST WAS SLIGHTLY SHOCKED - THE PROCEDURE WAS STOPPED IMMEDIATELY, THERE WAS NO PT HARM. THE ANESTHESIOLOGIST WAS NOT HARMED, SHE HAD A POSSIBLE BRUISING ON HER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEH-4 LITHOTRIPTER ELECTRO-HYDRAULIC LITHOTRIPTER FFK NORTHGATE TECHNOLOGIES, INC. AEH-4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA