BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 3951001 · Received July 22, 2014

    Report

    Report Number
    3006695864-2014-00351
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER WAS NOT PROVIDED AS TO NO PATIENT IMPACT OR CONSEQUENCE TO PATIENT. OUTCOMES ATTRIBUTED TO ADVERSE EVENT IS NOT SELECTED AS TO ADVERSE EVENT IS NOT REPORTED IN THIS REPORT AND DOES NOT APPLY TO PRODUCT PROBLEM. THE PHACOEMULSIFICATION MACHINE WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN ABBOTT FIELD SERVICE SPECIALIST (FSS). THE FSS ISOLATED THE PHACOEMULSIFICATION HANDPIECE THAT WAS PLUGGED INTO THE UNIT AT THE TIME OF THE EVENT. THE FSS VISUALLY INSPECTED THE UNIT AND FOUND A COMPONENT ON THE SUBSYSTEM CONTROLLER (SSC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS BURNT. THE COMPONENT WAS LOCATED UNDER THE MAX DRIVE POWER CABLE ON THE SSC PCBA. THE FSS REPLACED THE MAX DRIVE POWER CABLE, MAX DRIVE PCBA, THE PHACO CONNECTOR CABLE AND THE POWER SUPPLY. IN ADDITION, THE FSS TESTED AND CHECKED THE PHACOEMULSIFICATION HANDPIECE THAT WAS PLUGGED INTO THE UNIT AT THE TIME OF THE EVENT. FURTHERMORE, THE FSS TESTED AND CHECKED ALL OF CUSTOMER¿S HAND PIECES. ALL HANDPIECE PASSED AND ARE WORKING AS INTENDED. 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.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED A STRONG ODOR OF ELECTRICAL BURN AND POSSIBLE VISIBLE SMOKE. THE SURGERY CENTER HAD COMPLETED SEVERAL PROCEDURES SCHEDULED EARLIER IN THE DAY. THE MACHINE HAD PASSED THE PRIME AND TUNE STAGE AND HAD BEEN IDLING WHEN THE UNIT DISPLAYED A POWER SUPPLY-284 ERROR. THE UNIT SHUT DOWN AND THE SURGERY CENTER IMMEDIATELY UNPLUGGED THE MACHINE. IN ORDER TO FINISH REST OF SCHEDULED CASES FOR THE DAY, A BACKUP UNIT WAS BROUGHT IN TO COMPLETE SCHEDULE PROCEDURES. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427578 WHITESTAR SIGNATURE SYSTEM SIGNATURE HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1