BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIMA SE

    MDR report key: 112920 · Received August 8, 1997

    Report

    Report Number
    2914019-1997-00022
    Event Type
    Malfunction
    Date Received
    August 8, 1997
    Date of Event
    July 10, 1997
    Report Date
    July 10, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CO'S ANALYSIS OF THE DEVICE COULD NOT DUPLICATE THE PROBLEM. IN REVIEWING THE DESIGN CO HAS CONFIRMED THAT THE SAFETY CIRCUITS DO NOT ALLOW THE LASER TO PRODUCE DANGEROUS LIGHT. THE DESIGN HAS TWO FAIL SAFE SYSTEMS WHICH IF THE LASER DID LASE ON ITS OWN, THE POWER WOULD BE MINUMUM OR THE LASER WOULD SHUT ITSELF OFF. COHERENT BELIEVES THE LASER PERFORMED AS DESIGNED AND WAS SAFE EVEN THOUGH A POTENTIAL FAULT MAY HAVE OCCURRED. UNIT IS WORKING FINE AND HAS BEEN SHIPPED BACK TO THE CUSTOMER.

    Description of Event or Problem · 1

    DR PLACED LIO HEADSET DOWN, LASER FIRED INTERMITTENLY AT PRESET PARAMETERS BY ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMA SE OPHTHALMIC LASER HQF COHERENT MEDICAL LASER GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA