PAD

Description of Event or Problem

THIS COMPLAINT WAS RECEIVED ON THE 02 JUNE 2009 FROM REPORTER. A MALE WENT INTO ARREST WHILST SWIMMING. THE PT WAS PULLED OUT OF THE POOL BY OTHER SWIMMERS WHO STARTED PERFORMING CPR. THE PT'S BREATHING WENT IN/OUT SEVERAL TIMES THROUGHOUT CPR. THE RESPONDER RAN TO GET THE PAD WHICH WAS SITUATED ON THE WALL. THE RESPONDER OPENED THE PAD PAK AND TOOK THE PADS OUT, HE THEN REMOVED HIS GUARD SHIRT TO WIPE THE CHEST OF THE VICTIM. WHEN THE RESPONDER REMOVED THE PROTECTIVE COVERING ON THE PADS, THEY GOT STUCK TOGETHER, HE PULLED THEM APART AND APPLIED THEM TO THE PT. THE DEVICE BEGAN TO ANALYZE AND GAVE A "NO SHOCK ADVISED" MESSAGE. IMMEDIATELY, ANOTHER RESPONDER PULLED THE PADS OFF BEFORE STARTING CPR AGAIN. WHEN THE PADS WERE PULLED, A WIRE BECAME LOOSE ON THE BOTTOM RIGHT PAD (APEX PAD). THE RESPONDER ATTEMPTED TO PUT THE WIRE BACK INTO THE PAD. THE PADS WERE RE-APPLIED TO THE VICTIM, BUT THEY DID NOT APPEAR TO WORK PROPERLY. THE PARAMEDICS ARRIVED SHORTLY AFTER AND RELIEVED THE RESPONDERS. INVESTIGATION DETAILS. INSPECTION OF THE RETURNED PAD DEVICE DID NOT REVEAL ANY DEFECTS. THE DEVICE POWERED ON CORRECTLY WITH THE CORRECT AUDIO MESSAGES ISSUED. THE DEVICE SUCCESSFULLY DELIVERED THE CORRECT SEQUENCE OF SHOCKS WHEN SHOCK TESTED. DURING OUR INVESTIGATION, THE ECG RECORD WAS DOWNLOADED FROM THE DEVICE AND THE SHORT RHYTHM STRIP I.E. 22 SECONDS OF DATA WAS EXTRACTED. THE FOLLOWING COMMENTS PROVIDE THE RESULTING ANALYSIS: THE INITIAL 4 SECONDS OF THE RECORD WAS RECOGNIZED AS POSSIBLY BEING A SHOCKABLE RHYTHM. A FOLLOWING 4 SECOND WINDOW WAS THEN ANALYZED TO CONFIRM THE DECISION. DURING THE SECOND 4 SECOND PERIOD, THE UNUSUAL MORPHOLOGY OF THE VF WAVEFORM CAUSED THE DEVICE TO DISARM. THIS EVENT WAS REPEATED DURING THE 22 SECOND PERIOD AND OCCURRED AT 16.9 SECONDS. THE DEFIBRILLATOR RECOMMENDED THAT CPR PROCEED AFTER THE SECOND DECISION WAS MADE. THE RHYTHM APPEARS TO BE TORSADE-DE-POINTES WHICH IS A RARELY SEEN FORM OF VF. THE LARGE AMPLITUDE AND HIGH RATE TURNING POINTS MADE IT DIFFICULT FOR A CLEAR ALGORITHM DECISION. NORMALLY IN TORSADE-DE-POINTES THE RE-ENTRY PATHWAYS WILL FURTHER FRACTIONATE OVER A SHORT TIME WINDOW AND A MORE USUAL SHAPE OF VF WOULD HAVE BEEN DETECTED. UNFORTUNATELY, THIS MECHANISM DID NOT HAVE TIME TO EVOLVE AS THE ELECTRODES WERE REMOVED AT 22 SECONDS INTO THE INCIDENT. INSPECTION OF THE PAD-PAK RETURNED BY THE CUSTOMER CONFIRMED THAT THE DEFIBRILLATION ELECTRODE CABLE HAD BEEN RIPPED OFF THE ELECTRODE AT THE SECURING STUD, THE REMOVED ELECTRODE NOT HAVING BEEN RETURNED. THE SECURITY OF THE INTACT ELECTRODE WAS TESTED BY MANUALLY TUGGING. IT WAS FOUND THAT CONSIDERABLE FORCE WAS REQUIRED BEFORE THE CABLE DETACHED. HEARTSINE'S PAD DEFIBRILLATION ELECTRODES ARE MFG IN COMPLIANCE WITH THE APPROPRIATE STANDARD. THEREFORE, IT CAN BE CONCLUDED THAT THE CABLE WAS PULLED FROM THE DEFIBRILLATION ELECTRODE BY AN EXCESSIVE FORCE ABOVE WHICH THE PRODUCT IS REQUIRED TO WITHSTAND AS SPECIFIED. ACTIONS TAKEN: DEVICE WILL BE UPGRADED, RETESTED AND RETURNED TO THE CUSTOMER WITH A NEW USER MANUAL AND REPLACEMENT PAD-PAK FREE OF CHARGE.