BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREPOINT

    MDR report key: 3963155 · Received May 27, 2014

    Report

    Report Number
    2028159-2014-00968
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTRT
    Product Code
    HQF
    PMA / PMN Number
    K062624
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A SYSTEM LOCKED DURING A PROCEDURE. THERE IS NO KNOWN PT HARM. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310204 PUREPOINT LASER, OPHTHALMIC HQF ALCON - IRVINE TECHNOLOGY CTRT PUREPOINT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK