BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPRO

    MDR report key: 2551589 · Received March 8, 2012

    Report

    Report Number
    3005550372-2012-00005
    Event Type
    Other
    Date Received
    March 8, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 22, 2012
    Manufacturer
    BURKE L. MAYS AND ASSOCIATES, INC.
    Product Code
    GWQ
    PMA / PMN Number
    K050143
    Removal / Correction Number
    2012-05
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: EQUIPMENT PASSED STANDARDS ELECTRICAL SAFETY TESTING. PT DID RECEIVED AGGRESSIVE SENSOR ATTACHMENT AREA PREPARATION BY RUBBING TO REMOVE DRY SKIN THEN CLEANED WITH ALCOHOL WIPE. THIS IS STANDARD PROCEDURE. THIS MAY HAVE BEEN REASON PT COMPLAINED OF BURNING SENSATION. TRUE CAUSE REMAINS UNK.

    Description of Event or Problem · 1

    ON (B)(6) 2012 (CORRECTION): THE PT COMPLAINED OF A BURNING SENSATION ON HER RIGHT TEMPLE. THE NURSE NOTED THAT THE PT HAD A 0.75 CM BURN. ON (B)(6) 2012, I (B)(4), RECEIVED A CALL FROM (B)(6) HOSP IN (B)(6), STATING THAT HER EEG AMPLIFIER SERIAL NUMBER (B)(4) HAD BURNED A PT'S SCALP. THE PT WAS COMPLAINING THAT DURING THE STUDY HER SCALP WAS BURNING AND AFTER THE TEST THERE WAS A SMALL CIRCLE AREA ON HER HEAD THAT RESEMBLED A BURN MARK. AFTER DISCUSSING WITH THE TECHNICIAN, SHE TOLD ME THERE WAS ALREADY A SMALL SCAB ON HER SCALP AND SHE BELIEVED THAT THE ALCOHOL USED TO PREP THE SKIN MAY HAVE CAUSED HER SCALP TO BURN, AND FOLLOWING THE STUDY SHE PULLED THE SCAB OFF WHICH MADE IT LOOK LIKE A BURN MARK. THE EQUIPMENT STILL NEEDS TO BE CHECKED AND REPLACED TO MAKE SURE THERE ARE NO PROBLEMS WITH EEG AMPLIFIER SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPRO OMNIPRO/OMNIAMP (GWQ) OMNIPRO SYSTEM GWQ BURKE L. MAYS AND ASSOCIATES, INC. 360-8300 REVISION A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR