BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 200PS

    MDR report key: 2222897 · Received August 10, 2011

    Report

    Report Number
    2028159-2011-00932
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE REPORTED EVENT. THE COMPANY REPRESENTATIVE FOUND THE 30PSI REGULATOR TO BE AT 35.8PSI, BUT WAS ABLE TO ADJUST IT TO WITHIN SPECIFICATIONS. PREVENTATIVE MAINTENANCE WAS PERFORMED IN WHICH THE CPU BATTERY WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE 30PSI REGULATOR ADJUSTMENT AND CPU BATTERY ARE NOT RELATED TO THE REPORTED EVENT OF NO REFLUX. NO SAMPLES WERE RETURNED FOR EVALUATION, AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AT THE END OF A CASE NO SUCTION WAS AVAILABLE IN THE REFLUX MODE. THE CASSETTE AND FOOTSWITCH WERE CHANGED OUT, FOLLOWING A 10 MINUTE DELAY, AND THE CASE WAS COMPLETED WITH LOWER THAN NORMAL SUCTION. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 200PS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1