BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 2232951 · Received July 22, 2011

    Report

    Report Number
    2020664-2011-00037
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICALS (AMO)
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON INSPECTION AND ANALYSIS OF THE PHACOEMULSIFICATION UNIT, TERRITORY MGR FOUND PRIMING ERRORS WERE CAUSED BY A DRIP SPIKE ON THE TUBING PACK. THE BALL BEARING IN THE DRIP SPIKE PREVENTED THE BSS (BALANCED SALT SOLUTION) FROM FLOWING CORRECTLY, RESULTING IN PRIMING ERROR. THE TUBING PACK WAS NOT AVAILABLE FOR EVALUATION BY AMO. CUSTOMER THREW THE PACK AWAY BEFORE THE TERRITORY MGR COULD COLLECT THE PACK FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYSTEM FAILED TO PRIME. CUSTOMER POWERED DOWN THE SYSTEM 3 TIMES AND REBOOTED BUT WERE UNSUCCESSFUL IN PASSING PRIME/TUNE FUNCTION. PT WAS SEDATED AND NO INCISION HAD BEEN MADE YET. SURGERY WAS POSTPONED FOR 1 HOUR AND 15 MINUTES. THE PT REMAINED CLINICALLY STABLE DURING THE DELAY. PROCEDURE WAS COMPLETED WITH A BACK UP UNIT. NO PT INJURY REPORTED. GOOD OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITESTAR SIGNATURE SYSTEM PHACO MACHINE HQC ABBOTT MEDICAL OPTICALS (AMO) NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR