BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCU 56-CH PCI-64

    MDR report key: 2308191 · Received September 14, 2011

    Report

    Report Number
    2184149-2011-00013
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DQK
    PMA / PMN Number
    K092810
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THERE WAS NO EXTERNAL DAMAGED AROUND THE EXTERIOR OF THE SCU. FURTHER INSPECTION INSIDE THE SCU FOUND ALL EXPANSIONS CARDS WERE BENT OUT OF SHAPE AND THERE WERE DAMAGED PLASTIC CARD GUIDES. SEVERE THERMAL DAMAGE WAS OBSERVED ON THE DC/DC POWER SUPPLY (CONVERTER MODULE) AND BURNT TRACES ON THE PRESSURE INTERFACE CARD DUE TO POSSIBLE SHORT CIRCUIT THAT CREATES OVER CURRENT CONDITIONS. THE SCU WAS RECEIVED IN AN INOPERABLE CONDITION DUE TO THE UNSEATED EXPANSION CARDS. THIS CONDITION WOULD BE CAUSED BY THE UNIT POSSIBLY BEING DROPPED OR DAMAGED OR BY USER INTERVENTION. ALL EXPANSION CARDS WERE RESEATED AND THE PRESSURE INPUT CONDITIONING AND PRESSURE INTERFACE CARDS WERE TEMPORARILY REPLACED FOR EVALUATION. DURING FUNCTION TESTING, AC POWER AND THE POWER ON SELF-TEST (POST) WAS OBSERVED. THE SCU BOOTED UP CORRECTLY AND COMMUNICATED WITH THE WORKMATE PC AS EXPECTED. A COMMUNICATION TEST WAS PERFORMED AT THE RATE OF 2000 PACKETS PER SECOND WITHOUT MISSING PACKETS OR ERRORS. A PRESSURE CALIBRATION CHECK WAS PERFORMED. A PRESSURE TRANSDUCER SIMULATOR WAS CONNECTED TO THE SCU TO SIMULATE INVASIVE PRESSURE READINGS. ALL PRESSURE PARAMETERS WERE VERIFIED TO BE CALIBRATED WITHIN FACTORY SPECIFICATIONS. THE SCU PASSED THE SIGNAL ACQUISITION TEST, PACE DETECT AND PACING/ISOLATION TESTS. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. AFTER REPLACEMENT OF THE PRESSURE INPUT CONDITIONING AND PRESSURE INTERFACE CARDS, THE UNIT FUNCTIONED NORMALLY DURING FUNCTIONAL TESTING. IT IS SUSPECTED THE DAMAGE TO THE INTERNAL COMPONENTS AND REPORTED SMOKING OF THE AMPLIFIER WAS CAUSED BY AN EXTERNAL SOURCE. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH OPERATIONAL CONTEXT AS THE SAME EVENT OCCURRED TO THE REPLACEMENT SCU AS WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ABLATION PROCEDURE, THE SIGNAL CONDITIONING UNIT (SCU, AMPLIFIER) BEGAN TO SMELL BURNT AND SLIGHT SMOKE WAS SEEN. THE EP-WORKMATE RECORDING SYSTEM PASSED THE SELF TESTS DURING SYSTEM START UP. THE ISSUE OCCURRED WHEN THE CUSTOMER SWITCHED TO CHANNEL ONE OF THE EP-4 CARDIAC STIMULATOR. NO ALARM SOUNDED FROM THE SYSTEM, BUT THE ERROR "NO SIGNAL, CHECK CONNECTORS" APPEARED ON THE SCREEN. THE SCREEN OF THE EP-WORKMATE SYSTEM FROZE AND NO DATA WAS BEING RECEIVED FROM THE SCU. THE CUSTOMER CHECKED ALL CONNECTORS AROUND AND ON THE SCU WITH NO CHANGE. THE BURNT SMELL AND SLIGHT SMOKING OCCURRED. ABLATION HAD NOT YET BEGUN. A DIFFERENT SCU WAS USED TO PERFORM THE PROCEDURE. THERE WERE NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCU 56-CH PCI-64 PROGRAMMABLE DIAGNOSTIC COMPUTER DQK ST. JUDE MEDICAL, AF DIVISION 09-1462-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR