BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCUSCAN RXP

    MDR report key: 2150676 · Received June 22, 2011

    Report

    Report Number
    2028159-2011-00694
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    IYO
    PMA / PMN Number
    K842757
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT WRONG VALUES DISPLAYED WHEN PERFORMING BIOMETRY. THERE WAS NO SURGICAL IMPACT OR HARM TO THE PT. 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 - IRVINE TECHNOLOGY CENTER 8065741076 NA

    Patients

    Seq Age Sex Outcome Treatment
    1