BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CC

    MDR report key: 1930348 · Received November 18, 2010

    Report

    Report Number
    2028159-2010-02246
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    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
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. AFTER SPEAKING WITH TECHNICAL SUPPORT SERVICES, THE FACILITY ADJUSTED THE PSI TO SATISFY THE RECOMMENDED RANGE AND THE SYSTEM MESSAGE CLEARED. THE CPC CONNECTORS AND THE LATCH SEAL WERE REPLACED AS PREVENTIVE MAINTENANCE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED RECEIVING A SYSTEM MESSAGE, PRIOR TO BEGINNING SURGERY, INDICATING THE PRESSURE SOURCE NEEDED TO BE ADJUSTED. A PEDIATRIC CATARACT PT WAS ON THE TABLE AND HAD RECD' GENERAL ANESTHESIA. TECHNICAL SUPPORT SERVICES (TSS) WAS CONTACTED AND REQUESTED THE FACILITY LOOK AT THE WALL GAUGE TO DETERMINE THE PSI. THE FACILITY REPORTED THE PSI WAS SET AT 115. TSS ADVISED THE CUSTOMER THAT THE RECOMMENDED RANGE FOR PROPER OPERATION WAS BETWEEN 80-100. THE PRESSURE WAS ADJUSTED AND THE CASE WAS COMPLETED. THE START OF THE CASE WAS DELAYED FOR 15 MINUTES. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CC PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1