BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOVEREIGN COMPACT CONSOLE

    MDR report key: 3964762 · Received July 29, 2014

    Report

    Report Number
    3006695864-2014-00363
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOT PROVIDED, AS TO NO PATIENT INJURY IS REPORTED. THE CATEGORIES FOR OUTCOMES ATTRIBUTED TO ADVERSE EVENTS IS NOT APPLICABLE AS TO PRODUCT PROBLEM SELECTED. THE PHACOEMULSIFICATION MACHINE WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN ABBOTT FIELD SERVICE SPECIALIST (FSS). THE FSS VISUALLY INSPECTED THE UNIT AND FOUND BURNT COMPONENTS ON THE SUBSYSTEM CONTROLLER (SSC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND THE SINGLE BOARD COMPUTER (SBC) PRINTED CIRCUIT BOARD (PCB). THE FSS RECTIFY THE REPORTED ISSUE BY REPLACING THE SSC PCBA AND THE SBC PCB. THE FSS TESTED FOR ALL MODES OF OPERATION. PERFORM A FIELD SERVICE CHECKLIST. THE MACHINE WAS FOUND TO MEET AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    IN INITIAL REPORT, MODEL NUMBER IS INCORRECT. THE CORRECT MODEL NUMBER HAS BEEN PROVIDED. CMP680300. (B)(6). (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED AFTER THE COMPLETION OF CATARACT EXTRACTION PROCEDURE, THE COMPACT PHACOEMULSIFICATION UNIT HAD TURNED OFF AND WOULD NOT POWER ON. FURTHERMORE, THE CLINIC REPORTED VISIBLE SMOKE WITH AN ODOR EMITTING FROM THE INSIDE OF THE UNIT. THE CLINIC REPORTED NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441575 SOVEREIGN COMPACT CONSOLE SOVEREIGN COMPACT HQC ABBOTT MEDICAL OPTICS CMP680300

    Patients

    Seq Age Sex Outcome Treatment
    1