BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCUSCAN RXP

    MDR report key: 1891094 · Received October 22, 2010

    Report

    Report Number
    2028159-2010-02043
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP SPOKE WITH THE FACILITY AND RESOLVED THE ISSUE OVER THE TELEPHONE WITH ORIENTATIONS ABOUT HOW TO CONFIGURE THE RXP FOR PACHYMETRY AND PRINTING. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED PACHYMETER CONFIGURATION PROBLEMS AND WERE UNABLE TO PRINT. THE PT HAD RECEIVED ANESTHESIA. THE PROCEDURE WAS NOT COMPLETED AS THE STAFF WAS UNABLE TO CONFIGURE THE EQUIPMENT. MORE THAN 10 PROCEDURES WERE CANCELED. THERE WAS NO PT IMPACT REPORTED.

    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