BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREPOINT

    MDR report key: 1854334 · Received September 30, 2010

    Report

    Report Number
    2028159-2010-01867
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQF
    PMA / PMN Number
    K062624
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND CONFIRMED THE PROBLEM REPORTED. THE PCB WAS REPLACED AND THE CABLES WERE RESEATED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE NURSE REPORTED THE SYSTEM WON'T GO ABOVE 10 AND FREEZES WITH NO FIRING TONE. THE SYSTEM WAS SWITCHED OUT TO COMPLETE THE CASE. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK