BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPULSE (TM)

    MDR report key: 1250263 · Received December 4, 2008

    Report

    Report Number
    1419951-2008-00011
    Event Type
    Malfunction
    Date Received
    December 4, 2008
    Date of Event
    September 26, 2008
    Report Date
    December 4, 2008
    Manufacturer
    TRIMEDYNE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K041660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THE MANUFACTURER COMPLETED ALL INFORMATION ON THIS FORM BASED SOLELY UPON REPORT BY THIRD PARTY SERVICE ENGINEER. THE MANUFACTURER DID NOT EVALUATE THE DEVICE. NO CONSEQUENCES OR IMPACT TO PATIENT ON 10/23/2008, THE FOLLOWING WAS DETERMINED, "AFTER REVIEWING THE ATTACHED PHOTOS, IT DOES NOT APPEAR THAT THERE WAS ANY VISUAL CONCLUSIVE EVIDENCE THAT THE "T1 TRANSFORMER WAS TOTALLY BURNT" AS YOU REPORTED." DEVICE BEING EVALUATED BY THIRD PARTY.

    Description of Event or Problem · 1

    ON 9/19/2008, IT WAS ORIGINALLY REPORTED BY THE CUSTOMER THAT THE "LASER IS NOT WORKING SINCE 2005, BECAUSE THE HIGH VOLTAGE POWER SUPPLY HAS A PROBLEM." IN 2008, IT WAS REPORTED BY THE CUSTOMER THAT "THE HIGH VOLTAGE POWER SUPPLY HAS A PROBLEM BECAUSE THE TRANSFORMER T1 IS TOTALLY BURNED." THREE DAYS LATER, IT WAS REPORTED BY THE CUSTOMER THAT "THE PROBLEM WITH THIS LASER HAPPENED DURING THE INSTALLATION, NOT DURING THE PROCEDURE. DURING THE INSTALLATION, AS SOON AS THE LASER WAS SWITCH ON, I FELT A BURN SMELL, SO I TURNED THE LASER TO OFF POSITION IMMEDIATELY. DURING THE INSPECTION, I DISCOVERED THE TRANSFORMER T1 BURNED AND HOT." ALSO, "THERE WAS NOT ANY INJURY OR DEATH ASSOCIATED WITH THIS LASER." THIS INFORMATION IS DOCUMENTED AS REPORTED TO TRIMEDYNE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPULSE (TM) HOLMIUM YAG LASER SYSTEM GEX TRIMEDYNE, INC. 1210

    Patients

    Seq Age Sex Outcome Treatment
    1