BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 2043039 · Received March 25, 2011

    Report

    Report Number
    2028159-2011-00297
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Report Date
    February 28, 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
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM, REPLACED THE PRESSURE/VACUUM MANIFOLD, AND PERFORMED MAINTENANCE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. ROOT CAUSE HAS NOT BEEN DETERMINED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 03/25/2011. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A SYSTEM MESSAGE WAS DISPLAYED. THE CASSETTE WAS EXCHANGED THREE TIMES, BUT THE PROBLEM PERSISTED. THE PT WAS TRANSFERRED TO ANOTHER ROOM AND THE SURGERY WAS COMPLETED WITH ANOTHER SYSTEM. THERE WAS A DELAY OF ONE HR. PT STATUS IS UNK. ADDITIONAL INFO HAS BEEN REQUESTED.

    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