BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREPOINT

    MDR report key: 1819577 · Received August 18, 2010

    Report

    Report Number
    2028159-2010-01501
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Report Date
    July 19, 2010
    Manufacturer
    ALCON - IRVINCE TECHNOLOGY CENTER
    Product Code
    HQF
    PMA / PMN Number
    K062624
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SVC REP EXAMINED THE SYSTEM AND VERIFIED THE ERROR CODES RECEIVED. THE PHOTO-SENSOR ASSEMBLY WAS ADJUSTED FOR FREE MOVEMENT FROM PORT 1 TO PORT 2. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT HARM/INJURY." (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED." (DEVICE DISPLAYS ERROR MESSAGE). A BIOMEDICAL ENGINEER REPORTED A SYSTEM MESSAGE WAS DISPLAYED DURING A CASE. THE SYSTEM WAS REBOOTED MULTIPLE TIMES TO CLEAR THE MESSAGE. THE MESSAGE WAS CLEARED AND THE CASE WAS COMPLETED. THERE WAS A REPORTED DELAY IN THE CASE OF 15-20 MINS. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUREPOINT LASER, OPHTHALMIC HQF ALCON - IRVINCE TECHNOLOGY CENTER PUREPOINT NA

    Patients

    Seq Age Sex Outcome Treatment
    1