BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOVEREIGN COMPACT CONSOLE

    MDR report key: 5112773 · Received September 30, 2015

    Report

    Report Number
    3006695864-2015-00661
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    September 3, 2015
    Report Date
    February 11, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). DEVICE MANUFACTURE DATE: THE INFORMATION WAS REQUESTED AND HAS NOT YET BEEN RECEIVED. THE FIELD SERVICE SPECIALIST (FSS) VISITED CUSTOMER SITE TO INSPECT THE UNIT. THE FSS CHECKED THE SYSTEM AND FOUND BATTERY LEAKAGE IN SINGLE BOARD COMPUTER (SBC) PRINTED CIRCUIT BOARD (PCB); THEREFORE, THE SINGLE BOARD COMPUTER PCB WAS REPLACED. FSS CHECKED ALL PARAMETERS AND FUNCTION AS PER ABBOTT MEDICAL OPTICS (AMO) CHECKLIST. THE UNIT WAS FOUND WORKING FINE AND IT MET AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: 10/2/2009. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO ALTERNATING CURRENT (AC), THAT THE SYSTEM WOULD NOT TURN ON AND THAT SMOKE CAME OUT OF THE MACHINE. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO PATIENT TREATMENTS DELAYED OR CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645818 SOVEREIGN COMPACT CONSOLE PHACOFRAGMENTATION UNIT HQC ABBOTT MEDICAL OPTICS CMP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown