BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCUSCAN RXP

    MDR report key: 2222902 · Received August 10, 2011

    Report

    Report Number
    2028159-2011-00924
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ALCON - IRIVNE TECHNOLOGY CENTER
    Product Code
    IYO
    PMA / PMN Number
    K842757
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND WAS FOUND TO BE OPERATING NORMALLY. THE CUSTOMER WAS USING THE WRONG TECHNIQUE. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL RELATED REPORTS FOR THIS SYSTEM. THE ROOT CAUSE OF THE REPORTED INCORRECT MEASUREMENTS WAS ATTRIBUTED TO USER TECHNIQUE. THE SYSTEM WAS FOUND TO BE OPERATING NORMALLY. PER THE SYSTEM OPERATOR'S MANUAL, A WARNING STATES TO "ENSURE THAT THE CORRECT TECHNIQUE (CONTACT OR IMMERSION) IS SELECTED FOR THE TECHNIQUE BEING PERFORMED. INCORRECT TECHNIQUE SELECTION WILL IMPACT THE ACCURACY OF THE RESULTS". (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE BIOMETRY RESULTS WERE INACCURATE WHEN COMPARED TO THE PATIENT'S EXAMINATION RESULTS. THERE WAS NO HARM OR IMPACT TO THE PATIENTS INVOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCUSCAN RXP ULTRASONIC PULSED ECHO IMAGING SYSTEM IYO ALCON - IRIVNE TECHNOLOGY CENTER 8065741076 NA

    Patients

    Seq Age Sex Outcome Treatment
    1