Description of Event or Problem · 1
DURING SURGICAL PROCEDURE, A SYNCHRONIZED CARDIOVERSION ATTEMPT WAS MADE WITH THE DEVICE IN MANUAL MODE. UPON PRESSING THE SYNC BUTTON AND OBSERVING PROPER OPERATION, THE DEFIBRILLATOR WAS CHARGED TO 360J. AFTER A SHORTER THAN EXPECTED TIME, THE UNIT APPEARED TO BE READY FOR DISCHARGE. UPON DISCHARGE, THE UNIT GAVE EITHER A "CONNECT ELECTRODES" OR A "REMOVE TEST PLUG" MESSAGE. WE ARE NOT SURE WHICH. THE UNIT GAVE A SERVICE LIGHT AND CONTINUED TO GIVE THE MESSAGE. ANOTHER DEFIBRILLATOR HAD TO BE OBTAINED TO PROVIDE THERAPY NEEDED BY THE PATIENT. PADS CHECKED AND COMPATIBLE WITH DEFIB.====================== MANUFACTURER RESPONSE FOR DEFIBRILLATOR, LIFEPAK 20======================WITH RISK MGMT. APPROVAL, CALL WAS PLACED FOR FIELD SERVICE SUPPORT SINCE THE UNIT IS UNDER WARRANTY. THE UNIT GAVE A 9021 ERROR CODE AT THE TIME OF THE FAILURE. THEIR SERVICE DOCUMENTATION INDICATES THAT NEWEST SOFTWARE SHOULD BE INSTALLED AS THE CORRECTIVE ACTION FOR THIS. SERVICE REP INSTALLED LATEST SOFTWARE INSTALLED MATERIAL:QTY = 1 3203332-019 KIT-UPGRADE,SW,MODULE 070,LP20,ENGLISHUPON FURTHER CONSIDERATION, THE REP TOOK THE UNIT WITH HIM TO DELIVER TO REGULATORY AFFAIRS WITH THE COMPANY. HE UPDATED SOFTWARE ON ALL OTHER UNITS IN OUR OR AREAS. I AM CURRENTLY TRYING TO MAKE CONTACT WITH THE REPRESENTATIVE IN REGULATORY AFFAIRS TO TRY TO GET THIS SOFTWARE INSTALLED ON THE REST OF OUR UNITS. WE HAVE 79 OF THEM WITHIN OUR FACILITIES.