BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 1843378 · Received September 22, 2010

    Report

    Report Number
    2028159-2010-01794
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS TAKEN TO THE FACILITY BIOMEDICAL DEPT. THE BIOMEDICAL ENGINEER WAS GOING TO TRY DRYING OUT THE FLUID LEVEL SENSORS. THE CUSTOMER WAS PROVIDED A LOANER SYSTEM. THE FACILITY DID NOT REQUEST SERVICE. NO SAMPLES WERE RETURNED FOR EVALUATION. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE NURSE REPORTED THE SYSTEM WOULD NOT PRIME. THE CASSETTE BAG WAS FILLING WITH AIR. THE SYSTEM WAS REBOOTED THREE TIMES. THE TUBING, CASSETTES AND HANDPIECES WERE SWITCHED OUT THREE TIMES WITHOUT SUCCESS. ON THE THIRD REBOOT THE NURSING STAFF PUSHED THE 'SKIP BUTTON' AND THE CASE WAS ABLE TO PROCEED TO COMPLETION. THERE WAS A 15 MINUTES DELAY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK