BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCUSCAN RXP

    MDR report key: 2092159 · Received April 27, 2011

    Report

    Report Number
    2028159-2011-00430
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 28, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY REP EXAMINED THE SYSTEM AND RESEATED THE CABLES. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE EQUIPMENT DISPLAYED ALTERATION IN THE PROBE AGAIN DURING BIOMETRY TESTING. ADDITIONAL INFO PROVIDED FROM THE CUSTOMER INDICATED THE LENS POWER CALCULATIONS WERE VERY DIFFERENT THAN THE EXPECTED POWER. THE DIAGNOSTIC TEST WAS CANCELED AND RESCHEDULED FOR ANOTHER DAY. THERE WAS NO HARM OR INJURY TO THE PT. IN ADDITION, THE CUSTOMER REPORTED EXPERIENCING THE SAME ISSUE AGAIN ON THE SAME DAY HOWEVER, THE SYSTEM WAS REBOOTED AND THE TEST WAS COMPLETED WITHOUT FURTHER INCIDENT.

    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