BEUDAMED
    FDA Adverse Event Death Summary report: N

    PAD PRO MULTIFUNCTION ELECTRODE WITH R2 CONNECTOR

    MDR report key: 4596309 · Received March 12, 2015

    Report

    Report Number
    1320894-2015-00004
    Event Type
    Death
    Date Received
    March 12, 2015
    Date of Event
    February 13, 2015
    Report Date
    February 13, 2015
    Manufacturer
    CONMED CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K020203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (1) "USED/CONTAMINATED" PADPRO MULTIFUNCTION ELECTRODE (MFE) WAS RETURNED TO CONMED CORPORATION FOR EVALUATION. THE DEVICE WAS RECEIVED IN AN OPEN FACTORY PACKAGING THAT IDENTIFIED THE REPORTED CATALOG AND LOT NUMBERS. THE RETURNED DEVICE WAS THOROUGHLY EXAMINED BY THE R&D PROJECT ENGINEERS AND THE QUALITY ENGINEER AND THE EVALUATION FINDINGS ARE AS FOLLOWS: - ONE (1) OF THE TWO (2) FEMALE SOCKETS IN THE CONNECTOR HAD BEEN PUSHED INTO THE CONNECTOR HOUSING. - THE SOCKET WAS SEVERELY BENT AND A PIECE OF THE HOUSING HOLE HAD BROKEN OFF ONTO A SOCKET PRONG, SUGGESTING THAT A CONSIDERABLE FORCE WAS APPLIED TO THE SOCKET DURING THE INITIAL PLUGGING OF THE DEVICE INTO THE AED. - THE DAMAGED OUTLINE OF THE HOUSING SHOWS THAT BOTH SOCKET WINGS WERE ENGAGED IN THE HOUSING. - THERE WAS A FLAT SPOT, (I.E., DAMAGE ON THE DISTAL END OF THE SOCKET) THAT HAD PUSHED THROUGH THE CONNECTOR. - WHEN THE SOCKET WAS REINSERTED INTO THE HOUSING HOLE, THE SOCKET COULD NOT BE PULLED OUT MANUALLY. THE SOCKET WAS ABLE TO BE FULLY SEATED. - AN R2 MOLEX ADAPTOR WAS THEN ATTACHED TO THE CONNECTOR WITHOUT OBSTRUCTION AND CONTINUITY WAS VERIFIED BETWEEN THE ADAPTOR AND GEL PADS. EVIDENCE SUGGESTS THAT THE CONNECTOR SOCKETS HAD INITIALLY BEEN FULLY SEATED INTO THE CONNECTOR. THE MATING CONNECTOR WAS NOT CENTERED PROPERLY ON THE SOCKET WHEN THE ATTEMPT TO CONNECT THE PADS WAS MADE. A HIGH AMOUNT OF FORCE WAS APPLIED TO THE DISTAL RIM OF THE SOCKET BY THE MATING CONNECTOR PIN, PUSHING THE SOCKET THROUGH THE BOTTOM OF THE HOUSING. THE RIM OF THE SOCKET MAY HAVE BEEN TRAPPED BETWEEN THE CROWN OF THE MALE PIN AND THE WALL OF THE HOUSING, NOT ALLOWING IT TO SELF-CENTER AROUND THE PIN, CAUSING THE FORCE TO BE APPLIED DIRECTLY TO THE RIM OF THE SOCKET. NO MANUFACTURING ISSUE OR DEFECTIVE PARTS WERE IDENTIFIED. THE DEVICE WAS MANUFACTURED 28-OCT-2013. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT FOUND NO NOTED DISCREPANCIES DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED INCIDENT. OF THE LOT CONTAINING (B)(4) UNITS, THERE WERE NO OTHER SIMILAR COMPLAINTS RECEIVED. THE LOT OF R2 CONNECTORS UTILIZED IN THIS LOT WAS ALSO USED IN FIVE (5) ADDITIONAL LOTS OF MFES AND A TOTAL OF (B)(4) UNITS WITH NO CUSTOMER COMPLAINTS RECEIVED FOR ANY SIMILAR ISSUES. A TWO YEAR REVIEW OF PRODUCT HISTORY FOR THE PADPRO FAMILY OF DEVICES SHOWS THIS AS AN ISOLATED INCIDENT. (B)(4). THE PADPRO MFE IS A SINGLE-USE, DISPOSABLE DEVICE INTENDED FOR USE DURING DEFIBRILLATION, CARDIOVERSION, PACING, AND ECG MONITORING APPLICATIONS. A THOROUGH INVESTIGATION OF THIS REPORTED INCIDENT REVEALED THAT A BACK-UP DEVICE WAS AVAILABLE TO THE FIRST RESPONDER TEAM; HOWEVER, THAT BACK-UP DEVICE HAD BEEN LEFT BEHIND IN THE AMBULANCE AND WAS NOT READILY AVAILABLE AT THE EMERGENCY SITE. A MEMBER OF THE FIRST RESPONDER TEAM TRAVELED BACK TO THE AMBULANCE TO PROCURE THE BACK-UP PADPRO MFE; YET, ON ARRIVAL BACK AT THE EMERGENCY SCENE THE ALS, ADVANCED LIFE SUPPORT, TEAM HAD ARRIVED AND THE FIRST RESPONDER TEAM HAD BEEN RELIEVED OF THEIR RESPONSIBILITY FOR PATIENT CARE. AS PART OF THE INVESTIGATION, INQUIRIES IN REFERENCE TO WHAT CARDIAC RHYTHM THE PATIENT WAS IN ON ARRIVAL OF THE ALS TEAM. HOWEVER, THE ALS TEAM WAS FROM A DIFFERENT INSTITUTION THAN THE FIRST RESPONDER TEAM FROM THE (B)(6) RED CROSS, WHO WAS UNABLE TO OBTAIN THE ANSWER TO THE INQUIRIES. THE FIRST RESPONDER TEAM DID REPORT THAT NO SHOCK WAS DELIVERED BY THE ALS TEAM, WHICH INDICATED THAT THE PATIENT WAS NOT IN A SHOCKABLE CARDIAC RHYTHM REQUIRING THE UTILIZATION OF A DEFIBRILLATOR SHOCK. THIS SHOWS THAT THE FAILURE OF THE AED TO RECOGNIZE THE CONMED PADPRO MFES WAS NOT A DIRECT CAUSE OF THE PATIENT DEATH IN THIS INCIDENT. SUBSEQUENT TO THIS REPORTED INCIDENT, THE (B)(6) RED CROSS HAS UTILIZED THE SAME AED INVOLVED IN THIS INCIDENT TO SUCCESSFULLY DEFIBRILLATE AT LEAST ONE PATIENT UTILIZING THE SAME CATALOG NUMBER, 2516R OF PADPRO MFES. TO REDUCE RISK OF PRODUCT FAILURE AND/OR PATIENT INJURY THE INSTRUCTIONS FOR USE, IFU, PROVIDES THE FOLLOWING WARNINGS AND PRECAUTIONS: - DO NOT FOLD, TRIM, CRUSH, OR STORE UNDER HEAVY OBJECTS - DO NOT EXCEED A SETTING OF 360 JOULES WHILE DEFIBRILLATING PATIENTS - MAKE SURE THE SKIN IS DRY, I.E. FREE OF WATER, SWEAT, ALCOHOL, ETC. - IF THE ELECTRODES DO NOT ADHERE PROPERLY TO THE PATIENT, APPLY A NEW PAIR. - DO NOT REAPPLY IF REMOVED.

    Description of Event or Problem · 1

    A FIRST RESPONSE UNIT IN (B)(6) "AMBULANCE SERVICE - BASIC LIFE SUPPORT ONLY (BLS)" RESPONDED TO A CARDIAC ARREST EVENT. THE FIRST RESPONSE UNIT ARRIVED ON THE SCENE APPROXIMATELY EIGHT (8) MINUTES AFTER RECEIVING THE EMERGENCY CALL. THE AED (AUTOMATIC EXTERNAL DEFIBRILLATOR) DID NOT RECOGNIZE THE CONMED PADPRO MFES (MULTIFUNCTION ELECTRODES) AND THE TEAM WAS UNABLE TO GET A CARDIAC RHYTHM. WITH THE MFES UNABLE TO BE RECOGNIZED BY THE AED THE FIRST RESPONSE UNIT PROVIDED CPR (CARDIOPULMONARY RESUSCITATION) ONLY AT THE TIME. IT WAS FURTHER REPORTED THAT A MEMBER OF THE FIRST RESPONSE TEAM WENT BACK TO THE AMBULANCE TO PROCURE A SECOND PADPRO MFE. HOWEVER, BY THE TIME THE FIRST RESPONSE TEAM MEMBER ARRIVED BACK AT THE EMERGENCY SCENE, THE ADVANCED LIFE SUPPORT (ALS), TEAM HAD ARRIVED AND HAD TAKEN OVER PATIENT CARE. THE EVALUATION OF THE PATIENT'S CARDIAC RHYTHM WAS DELAYED UNTIL THE ARRIVAL OF THE ALS TEAM. IT IS NOT KNOWN WHAT WAS PERFORMED BY THE ADVANCED LIFE SUPPORT TEAM ONLY THAT THE PATIENT COULD NOT BE RESUSCITATED AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171563 PAD PRO MULTIFUNCTION ELECTRODE WITH R2 CONNECTOR PADPRO DEFIB PADS MKJ CONMED CORPORATION Y101413-05

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death WELCH ALLYN AED MODEL AED 20