BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMETER LENSTAR LS 900

    MDR report key: 2556039 · Received April 27, 2012

    Report

    Report Number
    1000176188-2012-00001
    Event Type
    Malfunction
    Date Received
    April 27, 2012
    Date of Event
    March 29, 2012
    Report Date
    April 27, 2012
    Manufacturer
    HAAG-STREIT AG
    Product Code
    HJO
    PMA / PMN Number
    K082891
    Removal / Correction Number
    CAPA 2012-03
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PROBLEM ANALYSIS HAS SHOWN, THE ROOT CAUSE OF THE PROBLEM WERE AN OMISSION IN THE EYESUITE SETUP MANUAL AND A USER ERROR OF THE HAAG-STREIT SERVICE TECHNICIAN. NEITHER THE BIOMETER LS 900 NOR THE EYESUITE SOFTWARE HAVE CONTRIBUTED TO THE PROBLEM. CONCLUSIONS, IS THE HAAG-STREIT SERVICE TECHNICIAN AND NOT THE OPHTHALMOLOGIST.

    Description of Event or Problem · 1

    THE HOSPITAL HAS A BIOMETER LENSTAR LS 900. THE OPERATING SOFTWARE EYESUITE IS INSTALLED ON SEVERAL COMPUTERS. THE COMPUTERS ARE CONNECTED WITH EACH OTHER IN A NETWORK. A DOCTOR AT THE HOSPITAL WANTED TO HAVE THE SOFTWARE ON HIS COMPUTER TO BE UPDATED. THE HAAG-STREIT SERVICE TECHNICIAN INSTALLED THE NEW SOFTWARE VERSION VIA REMOTE ACCESS ON THIS COMPUTER ONLY. HE ASSUMED THAT THERE WAS NO OTHER CLIENT RUNNING AT THIS TIME. THIS PROVED TO BE WRONG. IN RESULT, TWO DIFFERENT VERSIONS OF THE SOFTWARE WERE INSTALLED ON COMPUTERS IN THE SAME NETWORK. IF AN UPDATED CLIENT OF EYESUITE IS STARTED WHILE A CLIENT WITH AN OLDER VERSION OF EYESUITE IS STILL RUNNING, THEN DATABASE CORRUPTION MAY OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMETER LENSTAR LS 900 LENSTAR HJO HAAG-STREIT AG LS 900

    Patients

    Seq Age Sex Outcome Treatment
    1