BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-FUNCTION ELECTRODE - PADPRO

    MDR report key: 2907460 · Received January 10, 2013

    Report

    Report Number
    1320894-2013-00002
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 13, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K014209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE RETURN IS ANTICIPATED; HOWEVER, NOT RECEIVED TO DATE. END-USER FACILITY IS CHECKING WITH THEIR RISK MANAGEMENT DEPARTMENT TO SEE IF DEVICE CAN BE RETURNED TO CONMED CORPORATION FOR EVALUATION. NO PATIENT OR END-USER INJURY; HOWEVER, THE INABILITY OF THE DEVICE TO PERFORM AS EXPECTED MAY PUT THE PATIENT AT RISK. THIS IS A REPORTABLE MALFUNCTION FOR A MALFUNCTION OF THIS TYPE, IF IT OCCURRED AGAIN, COULD POSSIBLY LEAD TO A DEATH OR SERIOUS DETERIORATION IN THE HEALTH OF THE PATIENT. ON COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION OF THIS REPORTED INCIDENT A SUPPLEMENTAL REPORT WILL BE FILED. RETURN ANTICIPATED; NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    THE PADPRO MFE, MULTI-FUNCTION ELECTRODE, IS INTENDED FOR USE DURING DEFIBRILLATION, CARDIOVERSION, PACING, AND ECG MONITORING APPLICATIONS. THIS PRODUCT IS A SINGLE USE, DISPOSABLE DEVICE. DHR / LHR, DEVICE HISTORY RECORD / LOT HISTORY RECORD, REVIEW WAS NOT COMPLETED BECAUSE THE LOT NUMBER OF THE DEVICE WAS NOT AVAILABLE. ONE (1) 2001H-C PADPRO MULTI-FUNCTION ELECTRODE WAS RETURNED REGARDING A CUSTOMER COMPLAINT THE PADS ON THE DEVICE WERE FOUND TO BE FOLDED OVER ON THEMSELVES. THE PADS WERE SLOWLY UNFOLDED AS NOT TO DESTROY THE GEL LAYER. ONCE OPENED, THE PADS, WIRES AND COUPLING WERE EXAMINED. NO VISUAL DEFECTS WERE IDENTIFIED. THE GEL WAS FOUND TO BE FREE OF BODY HAIR AND SKIN. WIRE CONNECTIONS APPEARED TO BE FIRM. THE PAD TO CONNECTOR CONTINUITY WAS CHECKED USING A DIGITAL MULTIMETER. THE MEASUREMENTS OF THE TWO (2) PADS WERE 1.2 OHM AND 1.3 OHM. THESE RESISTANCE READINGS ARE BELOW THE STANDARD THRESHOLD OF 5.0 OHM. INSTRUMENTATION TESTING: THE RETURNED PADPRO MULTIFUNCTION ELECTRODE WAS CONNECTED TO A PHILIPS HEARTSTART MRX MONITOR/DEFIBRILLATOR. THE COUPLING WAS MADE EASILY AND THE CONNECTION WAS SOLID. THE PADS WAS ATTACHED TO FLUKE 7000DP DEFIBRILLATOR/EXTERNAL PACER ANALYZER. THE GEL ADHERED WELL WITH NO GAPS. USING AN ARRAY OF OUTPUTS, THE DEFIBRILLATOR SUCCESSFULLY DELIVERED 200 JOULES, 150 JOULES, 120 JOULES AND 50 JOULES TO THE ANALYZER VIA THE RETURNED PADS. THE MEASURED RESPONSES WERE 182.6 JOULES, 136.5 JOULES, 107 JOULES AND 45 JOULES RESPECTIVELY. THE DEVICE WAS ACTIVATED IN A SEQUENCE OF EIGHT (8) FIRINGS WITH NO FAILURES. A 24-MONTH REVIEW OF THE CUSTOMER COMPLAINT HISTORY FOR MULTI-FUNCTION ELECTRODE FAILURES HAS SHOWN ONE (1) SIMILAR COMPLAINT. THE PREVIOUS COMPLAINT WAS DETERMINED AS UNCONFIRMED AND NOT REPRODUCIBLE PRODUCT THE SAME RESULTS AS THIS PRESENT CASE.. LABORATORY EXAMINATION HAS FAILED TO CONFIRM THE CUSTOMER COMPLAINT OF "PADS DID NOT DISCHARGE". DURING LABORATORY TESTING, EVALUATION OF THE RETURNED DEVICE WAS NOT ABLE TO REPRODUCE THE CUSTOMER COMPLAINT. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED NOR CONFIRMED ANY MANUFACTURING DEFECTS ASSOCIATED WITH THE RETURNED DEVICE; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "WHEN USED ON A DEFIBRILLATOR, PADS DID NOT DISCHARGE. MOVED PADS TO ANOTHER MACHINE AND THEY DID NOT DISCHARGE THERE EITHER. LOT # UNKNOWN BUT MAY BE Y100412-07. CUSTOMER WILL CHECK WITH RISK MANAGEMENT TO SEE IF THEY GIVE TO OK TO HAVE THE PADS RETURNED TO US." DATE OF INCIDENT WAS REPORTED AS (B)(6) 2012. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13291 MULTI-FUNCTION ELECTRODE - PADPRO PADPRO-MFE MKJ CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1