ZOLL M-SERIES
Received Feb 25, 2019 · Event occurred Feb 15, 2019
Report 8382081 · MDR key 8382081
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
39 YR
- Death
- Death
Narrative
Description of Event or Problem
PATIENT FOUND UNRESPONSIVE AND NOT BREATHING . CODE BLUE CALLED, AND RESPONSE TEAM ARRIVED WITH CRASH CART. DEFIBRILLATOR CARDIAC MONITORING PADS APPLIED AND MACHINE TURNED ON, ASYSTOLE PER ZOLL MONITOR ((B)(4)). MEDICATIONS ADMINISTERED PER PHYSICIAN, PATIENT CONVERTED TO RHYTHM V-FIB. DEFIBRILLATOR PADS PUT ON PATIENT, ATTEMPTED CHARGE TO 120J AND MONITOR SHOWED ¿DEFIB PAD SHORT¿, CHANGED, ADJUSTED PADS AND ATTEMPTED CHARGE AGAIN. THE SAME MESSAGE CODE, ¿DEFIB PAD SHORT¿ WAS EXPERIENCED WITH THE SECOND SET OF PADS. BROUGHT SECOND DEFIBRILLATOR ((B)(4)) TO BEDSIDE, CONNECTED PADS, PUT PADS ON PATIENT, ATTEMPTED CHARGE, MONITOR READ ¿DEFIB PAD SHORT¿; CHANGED PADS AND MOVED PAD LOCATION (ONE ON BACK/ONE OVER HEART), CHANGED CABLES, ATTEMPTED CHARGE, MONITOR READ ¿DEFIB PAD SHORT¿. CHEST COMPRESSIONS CONTINUED ON PATIENT AND MEDICATIONS ADMINISTERED. AFTER CODING PATIENT FOR 25 MINUTES, PATIENT DEATH DECLARED BY PHYSICIAN IN ATTENDANCE. AFTER EVENT, BOTH DEFIBRILLATORS TESTED AND TEST RESULTS WERE POSITIVE, SHOWING THE MACHINES WERE READY FOR USE. BIOMED TESTED BOTH DEVICES ON 20 FEB 2019 , BOTH TESTED IN WORKABLE CONDITION. ACCORDING TO BOTH PHYSICIANS INVOLVED IN THE CARDIAC RESUSCITATION EVENT, THE PATIENT'S PATHOPHYSIOLOGY LIKELY RESULTED IN THE INABILITY TO CREATE THE APPROPRIATE CONDUCTION SECONDARY TO ASCITES, ANASARCA, LIVER AND KIDNEY DISEASE.