BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR SIGNATURE?ESYSTEM

    MDR report key: 3191394 · Received June 26, 2013

    Report

    Report Number
    2020664-2013-00030
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OPERATOR OF THE DEVICE: PHYSICIAN. INITIAL MDR AND FOLLOW UP #1, THE BOX FOR "ADDITIONAL MANUFACTURER NARRATIVE" SHOULD HAVE BEEN SELECTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN PROVIDED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ACCOUNT REPORTED THAT PATIENT'S HEALTH WAS NOT AFFECTED. ALTHOUGH, EDEMA WAS OBSERVED SLIGHTLY STRONGER THAN USUAL; THE PATIENT'S VISUAL ACUITY WAS 1.2 (20/16) AT THE EXAMINATION ON THE POSTOPERATIVE DAY ONE. THE FIELD SERVICE SPECIALIST (FSS) VISITED THE CUSTOMER. THE SYSTEM INSPECTION REVEALED THE GUI BOARD WAS CHARRED. THE FSE COLLECTED THE MACHINE IN QUESTION.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE MANUFACTURER REPORT NUMBER SHOULD HAVE BEEN 3006695864. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ODOR WAS CONFIRMED FROM EVIDENCE OF THE ORIGINAL PCBA (PRINTED CIRCUIT BOARD ASSEMBLY). THE ORIGINAL SIGNATURE CONSOLE (SN (B)(4)) IS OVER ONE YEAR OLD BASED ON THE CONSOLE SERIAL NUMBER, SO THIS PCBA WAS IN OPERATION AT LEAST A YEAR BEFORE FAILING. THE PCBA WAS PLUGGED INTO A WORKING SIGNATURE MONITOR AND WAS NON-OPERATIONAL. THE ELECTRICAL CIRCUIT WHICH C53 AND L15 ARE USED IS A FILTER CIRCUIT OF A 5 VOLT REGULATOR INPUT, WHICH SUPPLIES +5 VOLTS TO THE PCBA, SO A FAIR AMOUNT OF CURRENT IN THE ORDER OF 1 AMP PASSES THROUGH THESE SURFACE MOUNT COMPONENTS. C53 VOLTAGE MARKING COULD NOT BE VERIFIED DUE TO THE BURNED CASE, BUT THE CORRECT POLARITY MARKING WAS CONFIRMED COMPONENT L15 MARKING COULD NOT BE VERIFIED DUE TO IT WAS BURNED OFF THE BOARD, BUT IT IS NOT A POLARIZED DEVICE. INCORRECT COMPONENT INSTALLATION IS A LOW PROBABILITY DUE TO THE IN CIRCUIT TESTING STAMP EVIDENCE, SO THE POTENTIAL CAUSE OF THE COMPONENT FAILURE COULD BE THE DEFECTIVE COMPONENT OR PREMATURE/INFANT MORTALITY ¿ EITHER L15 OR C53 FAILED UNDER LOAD ¿ SHORTED AND BURNED BOTH COMPONENTS IN THE CIRCUIT, WITH L15 MELTING OFF THE BOARD ¿ CAUSING A +5 VOLT POWER FAILURE ON THE PCBA, AND MAKING THE SCREEN DISPLAY ¿BLACK OUT¿ DURING USE, HOWEVER A DEFINITIVE CAUSE CANNOT BE DETERMINED FOR THIS FAILURE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED IN CONDITION MAKING EVALUATION IMPOSSIBLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE MONITOR DISPLAY SUDDENLY BLACKED OUT DURING A SURGERY. ALSO, THE CUSTOMER SMELLED ODOR FROM THE SIGNATURE CONSOLE. THE CUSTOMER REBOOTED THE SYSTEM BUT IT FROZE PRIOR TO SELF-TEST. THE SURGERY WAS CONTINUED WITH ANOTHER SYSTEM (SOVEREIGN) OF THE CUSTOMER'S PROPERTY. ACCOUNT REPORTED THERE WAS DELAY OF 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289948 WHITESTAR SIGNATURE?ESYSTEM SIGNATURE HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other